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Senior Director, Quality Systems Lifecycle Management (R&D)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We put people first and are looking for people determined to make life better for people around the world.

Role Overview

The Senior Director, Quality Systems Lifecycle Management (R&D) oversees all processes within the Lifecycle Management pillar of the Quality Management System (QMS), focusing on research and development stakeholders. The role ensures the integrity and evolution of the process framework by establishing connections, standards, and governance to support R&D, Clinical, and Commercial Supply functions throughout the product lifecycle. It involves managing, monitoring, and reporting on Lifecycle Management processes, driving excellence by aligning with R&D priorities, ensuring compliance, and advancing quality initiatives.

High‑Level Responsibilities

Support teams and leaders of Global Process Owners (GPOs) for all R&D‑relevant processes within the Lifecycle Management pillar, including:

Drug & Device Development
Non‑Clinical/Discovery Programs
Clinical Management (trial design, site engagement, data analysis, and disclosure of research results)
Global Patient Safety
Regulatory affairs according to the QMS global process framework

Governance & Strategy

Align to QMS structured governance and monitoring models to deliver excellence across R&D processes in Lifecycle Management and the QMS.
Design and develop models for determining the health of the QMS process ecosystem, with a focus on Enterprise & R&D‑driven metrics and outcomes.
Proactively ensure compliance with global regulatory standards, scientific principles, and evolving industry trends in R&D.

Continuous Improvement

Drive process improvements and strategic decisions by analyzing and interpreting complex R&D data.
Monitor performance metrics, report, and provide insights to inform decision‑making and drive further improvements in R&D processes.

Leadership, Collaboration & Stakeholder Engagement

Develop, lead, mentor, and maintain the GPO community to collaborate on proposed improvements and deepen knowledge of R&D processes and tools.
Actively collaborate with enterprise‑wide teams on standardized global business processes related to R&D and product lifecycle.
Engage in external organizations and industry groups to monitor policy changes for regulatory/external environments and advocate/influence quality‑related policies and regulatory requirements in R&D.
Build and maintain an inventory of R&D stakeholders, including functional leads.
Identify and engage primary, secondary, and informed stakeholders for each process, ensuring robust communication, strategic document management, training, and delivery planning.
Collaborate with R&D teams to ensure processes are fit‑for‑purpose and support innovation, scientific rigor, compliance, and the increased value of Quality.

Basic Requirements

Bachelor’s degree (preferred in Business or Life Science‑related field).
10+ years’ experience in the pharmaceutical industry in business or quality operational roles, with significant understanding of research and development processes and/or clinical operations.

Additional Skills/Preferences

Proven ability to lead in a matrixed organization, influencing areas beyond direct control, especially in R&D environments.
Experience driving multi‑site or global improvement initiatives in R&D.
Strong strategic thinking with ability to execute strategic decisions while balancing conflicting priorities in research and development.
Skilled in analyzing complex R&D data to inform process improvements and strategic actions.
Demonstrated change agility in anticipating and leading others through change and ambiguity in scientific and regulatory contexts.
Excellent collaboration and communication skills across all organizational levels and formats.
Expertise in developing scalable and standardized processes across global R&D operations to improve efficiency and reduce complexity.
Influential leadership expertise and experience engaging with senior‑level R&D functional leads.
Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value‑added business results in R&D.
Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks in research and development.
Demonstrated people management experience.
Expertise in navigating and ensuring adherence to global regulatory standards and frameworks relevant to R&D.

Additional Information

Available to travel (domestic and international) when required (0–10%).
Desired location of this role is onsite at Indianapolis, IN with the ability to work from home 4 days per month; alternate Lilly locations will be considered based on availability and approval of hosting site.
Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodations to submit a resume, please complete the accommodation request form (

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $156,000 – $228,800. Full‑time equivalent employees will be eligible for a company bonus (depending in part on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day‑care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

#WeAreLilly

#J-18808-Ljbffr","shortDescription","

Senior Director, Quality Systems Lifecycle Management (R&D)

At Lilly, we unite caring with discovery to make life better for people...","promoted","title","Senior Director, Quality Systems Lifecycle Management (R&D)","duration","","experienceLevel","displayThumbnail","location","locations",[65],"id",["B","2734300637"],"displayHeadline","Work at Eli Lilly and Company","category","Creative & Design","displayPublishedAt","7 days ago","displayUrl","/jobs/2734300637-senior-director-quality-systems-lifecycle-management-rd","shortTitle","shortLocation","WorkFromHome, IN, United States","searchCompanyPath","/jobs?keyword=Eli+Lilly+and+Company","searchLocationPath","/jobs?location=WorkFromHome%2C+IN%2C+United+States","searchTitlePath","/jobs?keyword=Senior+Director%2C+Quality+Systems+Lifecycle+Management+%28R%26D%29",{"_66":67,"_68":69,"_70":71,"_72":73,"_74":75},"country","United States","city","WorkFromHome","formatted","WorkFromHome, IN, United States, 46262","state","IN","postal_code","46262",["D",1775383200000],"Lilly France","Senior Director, QMS Operational Controls

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.\nOverview of Role:\nThe Senior Director, QMS Operational Controls will provide central oversight of Operational Controls processes, ensuring alignment with the greater Quality Management System (QMS) in terms of strategy, infrastructure, and business tools. This role is essential in maintaining the integrity and evolution of the process framework by developing connections, standards, and governance to support commercial and Clinical Supply functions. The incumbent is accountable for health, management, and reporting across the Operational Controls pillar of the QMS framework. This leader will support excellence by aligning processes with business priorities, ensuring compliance, and driving quality improvements.\nHigh-Level Responsibilities:\nLead Global Process Owners (GPOs) of non-Quality-owned processes to deliver process excellence in the Operational Controls Pillar of the QMS framework.\nImplement a structured governance and monitoring model to deliver excellence beyond Quality-owned processes across the framework.\nDesign and develop, in partnership with Management Review, a model for determining the health of the QMS process ecosystem.\nConsult with Lilly manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, and other functions to educate on the quality system.\nProactively ensure compliance of Lilly's Quality Systems with various country agency standards, industry trends, and scientific principles.\nEnsure the Global Standard, Processes, Practices, Trainings, and implementation tools are implemented and maintained according to regulatory, industry, and company expectations.\nImplement and continuously improve governance that results in prioritization, decisions at the right level, and enables QMS ease of execution for required changes.\nEnsure processes are executed consistently across the organization and monitor signals to drive continuous improvement.\nDefine a common set of global effectiveness and efficiency measures to drive end-to-end QMS health, enable desired performance, and build capability expertise.\nPartner with document owners to obtain potential risks associated with document changes, including regulatory non-compliance, process interruptions, or misalignment between global entities. Develop strategies and contingency plans to mitigate these risks.\nMonitor performance metrics, report, and provide insights to inform decision-making to drive further improvements.\nDevelop, lead, mentor, and maintain the GPO community to collaborate on proposed improvements and deepen the knowledge of the associated processes and tools.\nActively collaborate with enterprise-wide teams on standardized global business processes.\nActively engage in external organizations and industry organizations to monitor policy changes for regulatory/external environments and advocate/influence quality-related policies and regulatory requirements.\nBasic Requirements:\n10+ years' experience in the pharmaceutical industry in business or quality operational roles across Research and Development or commercial manufacturing.\nBachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.\nAdditional Skills/Preferences:\nProven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.\nExperience leading a major multi-site or global functions improvement initiative.\nStrong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.\nAbility to drive process improvements and strategic decisions by analyzing and interpreting complex data.\nDemonstrated change agility in anticipating and leading others through change and ambiguity.\nExcellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.\nExpertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.\nDemonstrated influential leadership expertise and experience engaging with senior-level functional leads.\nStrong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.\nStrong capabilities in establishing governance structures and proactively addressing quality and regulatory risks.\nDemonstrated people management experience.\nExpertise in navigating and ensuring adherence to global regulatory standards and frameworks.\nAdditional Information:\nAvailable to travel (domestic and international) when required (ca. 10%).\nFluent in English; additional languages are also recommended.\nLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.\nLilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.\nOur employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.\nActual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200.\n","Senior Director, QMS Operational Controls

At Lilly, we unite caring with discovery to make life better for people around the world. We are...","Sr. Director -QMS Operational Controls",[90],["B","3158200348"],"Work at Lilly France","1 days ago","/jobs/3158200348-sr-director-qms-operational-controls","Indianapolis, IN, United States","/jobs?keyword=Lilly+France","/jobs?location=Indianapolis%2C+IN%2C+United+States","/jobs?keyword=Sr.+Director+-QMS+Operational+Controls",{"_66":67,"_68":91,"_70":92,"_72":73,"_74":75},"Indianapolis","Indianapolis, IN, United States, 46262",["D",1774609200000],"Philips Iberica SAU","A health technology company is seeking an Ultrasound QMS Director in Bothell, WA. This role encompasses overseeing multiple QMS functions and ensuring compliance with industry standards. Ideal candidates will have extensive experience in quality management, especially in regulated environments, and a strong background in leading teams. The position offers competitive compensation and aims to improve quality healthcare access through strategic quality initiatives.\n#J-18808-Ljbffr\n","A health technology company is seeking an Ultrasound QMS Director in Bothell, WA. This role encompasses overseeing multiple QMS functions and ensur...","Ultrasound QMS Director: Quality Strategy & Compliance",[107],["B","3030611703"],"Work at Philips Iberica SAU","10 days ago","/jobs/3030611703-ultrasound-qms-director-quality-strategy-compliance","Bothell, WA, United States","/jobs?keyword=Philips+Iberica+SAU","/jobs?location=Bothell%2C+WA%2C+United+States","/jobs?keyword=Ultrasound+QMS+Director%3A+Quality+Strategy+%26+Compliance",{"_66":67,"_68":108,"_70":109,"_72":110,"_74":111},"Bothell","Bothell, WA, United States, 98021","WA","98021",["D",1774609200000],"Job Title\nUltrasound QMS Director

Job Description\nUltrasound QMS Director

In this role you

Are responsible for overseeing the strategic management of the QMS department, aligning it with organizational goals and industry best practices.

Your role:

Manages and oversees multiple QMS functions, such as document control, internal audits, CAPA, and training programs, ensuring their effective implementation, compliance, and continuous improvement across the organization.

Collaborates with senior leadership to influence and align quality strategy with business objectives, ensuring that quality management processes support operational efficiency, risk management, and strategic growth.

Oversees the preparation and execution of regulatory inspections and external audits, acting as the key point of contact for auditors, and managing the response to findings to ensure timely and effective resolution.

Oversees the analysis of complex QMS data and trends across multiple functions to identify systemic issues, leads cross‑functional teams in root cause analysis, and drives the implementation of strategic quality improvement initiatives.

Acts as a key advisor on quality‑related risks and opportunities, providing expert guidance to executive leadership on regulatory changes, compliance risks, and quality trends to inform strategic decision‑making.

Takes responsibility for planning, staffing, budgeting, managing priorities, and proposing/implementing methodological changes for a function/region/business.

You're the right fit if:

Bachelor's / Master's Degree in Mechanical Engineering, Industrial Engineering, Science or equivalent.

8+ years of experience with Bachelor's OR 6+ years of experience with Master's in areas such as Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive.

Prefer 7+ years of experience in leading teams with direct and indirect reports in complex matrix organizations and delivering on organizational objectives.

You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

How we work together\nWe believe that we are better together than apart. For our office‑based teams, this means working in‑person at least 3 days per week. Onsite roles require full‑time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips\nWe are a health technology company. We built our entire company around the belief that every human matters, and we won’t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Learn more about our business.

Discover our rich and exciting history.

Learn more about our purpose.

Learn more about our culture.

Philips Transparency Details\nThe pay range for this position in Cambridge, MA is $180,600 to $252,000 Annually.

The pay range for this position in Bothell, WA is $180,600 to $252,000 Annually.

The pay range for this position in Reedsville, PA is $180,600 to $252,000 Annually.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job‑related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long‑term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information\nUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work‑authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge MA, Bothell WA, Reedsville PA.

#LI-PHI

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug‑free workplace.

#J-18808-Ljbffr\n","Job Title\nUltrasound QMS Director

Job Description\nUltrasound QMS Director

In this role you

Are responsible for overseein...","Ultrasound QMS Director",[120],["B","3030645941"],"/jobs/3030645941-ultrasound-qms-director","/jobs?keyword=Ultrasound+QMS+Director",{"_66":67,"_68":108,"_70":109,"_72":110,"_74":111},["D",1774931453000],"Arcus Biosciences","

Summary

The Quality Assurance (QA) department is seeking an experienced QA professional who will be responsible for assessing, improving and maintaining the Quality Management System (QMS). This is to ensure a state of cGMP compliance and support the effective execution of Quality Management Systems. The qualified candidate will partner with the Quality Assurance QMS, Sr. Director for continuous improvement of Quality Manual policies, procedures, work instructions and processes while also leading cross functionality to build a culture of quality.

Responsibilities

Design an architectural landscape for Quality Management System.
Assess, improve, and maintain the QMS elements including Quality Manual, policies, procedures, and controls, enabling successful and efficient processes to meet regulatory requirements.
Interact with quality and cross functional stakeholders on the performance of quality systems.
Ensure continuous improvement while keeping current with emerging and changing regulations, guidance documents, and industry best practices.
Provide cross functional quality leadership and act as Subject Matter expert for, at a minimum Deviation Management, CAPA & Effectiveness Check, Change Management, Document Control, Training Management, Product Complaints, Quality Management Reviews.
Oversee the performance and effectiveness of the Quality Management System programs as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity.
Monitor the state of control of Arcus Quality Management System.
Evaluate and identify improvement opportunities, utilize critical thinking, and apply problem solving skills, to improve and sustain product quality and process effectiveness in the overall QMS lifecycle.
Establish robust and comprehensive processes to assure corrective and preventive measures are systematically implemented and controlled.
Lead the revision of Quality Management Systems documents.
Implement a training program for Arcus GxP staff to maintain compliance with regulations and internal processes and procedures.
Train end users of the Quality Management System.
Provide metrics on the performance of QMS.

Qualifications

BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience and education.
15+ years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment.
Direct experience with key quality systems (e.g., Change Management, Deviations Management, CAPA and Effectiveness Check, Product Complaints, Training Management, Document Control and Quality Management Review).
Excellent working knowledge and understanding of GxP requirements, proficiency in applying regulatory and ICH guidelines.
Broad experience in the bio-pharmaceutical industry in small molecules and large molecules.
Experience with implementation and management of electronic quality management systems, experience with Veeva Vault is highly desired.
Experience developing and reporting quality metrics.
Excellent working knowledge of quality systems and GxP standards applicable to product life cycle from development to commercial.
Ability to prioritize and partner with other functions to meet deadlines efficiently.
Ability to provide internal training i.e. SOPs and Policies with excellent public speaking skills.
Proficient with the Visio, Microsoft Office software, including Word, Excel, PowerPoint experience with Project a plus.
Excellent verbal and written communication skills (e.g., listening skills, ability to interpret and summarize information and clear and concise communication skills).
Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
Strong interpersonal skills and the ability to assist personnel in a fast-paced environment and the ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
Highly ethical, self-motivated and self-directed.
Works effectively and independently as well as in a team environment.
The ability to effectively interact with internal peers and site management to lead continuous improvement.
Demonstrate accountability in a fast-paced environment and work independently with a high degree of flexibility.
Possess positive attitude, and strong interpersonal skills.
Ability to work effectively in a team environment with exceptional interpersonal skills, and attention to details.
A self-starter individual, highly motivated with high level of initiative and strategic planning.
Provide clear directions to internal stakeholders.
Possess a leadership style and not a follower in project setting and group meetings.
Customer Service approach.

Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and a computer screen; and hearing and speech to communicate in person, before groups, and over the telephone. This is primarily a sedentary office classification although standing in work areas and walking between work areas may be required. Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard, mouse, or calculator, and to operate standard office equipment. Positions in this classification occasionally bend, stoop, kneel, reach, push, and pull drawers open and closed to retrieve and file information. Employees must possess the ability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.

This role will be based at our Hayward, CA location. The anticipated salary range for fully qualified candidates applying for this position is $185,000 - $195,000 USD annually. This salary range is an estimate of what we reasonably expect to pay for this posted position. The actual salary may vary based on various factors including, without limitation, individual education, experience, tenure, skills and abilities, internal equity and alignment with market data. In addition to a competitive market-based salary, Arcus offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package. Additional information about our total rewards program can be found here:

EOE

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

#LI-JS1

#J-18808-Ljbffr","

Summary

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Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

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