Director, Bioresearch Quality Process Management
Johnson & Johnson, New Brunswick, NJ, United States
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
We provide an inclusive work environment where each person is considered as an individual.
At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Quality
Job Sub
Function: Multi-Family Quality
Job Category: People Leader
All Job Posting Locations: Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, Miami, Florida, United States of America, Mountain View, California, United States of America, New Brunswick, New Jersey, United States of America, Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Santa Clara, California, United States of America
Job Description: Johnson & Johnson is recruiting for a
Director, Bioresearch Quality Process Management , located at one of the identified Johnson & Johnson Medtech sites:
New Brunswick, NJ; Mountain View, CA; Cincinnati, OH; Jacksonville, FL; Miami, FL; Raritan, NJ; Irvine, CA; Palm Beach Gardens, FL; Santa Clara, CA
and
Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Director, Bioresearch Quality Process Management, is a highly experienced and strategic leader accountable to spearhead Bioresearch related quality process enhancements and governance. In partnership with MedTech Bioresearch R&D Quality functional leads and MedTech Q&C Centers of Excellence, this critical role is instrumental in enabling transparency of bioresearch quality risks across MedTech Business Units, with fit for purpose and standardized quality processes & approaches in support of pre-clinical, clinical, medical safety and pharmacovigilance quality program activities. The role will also ensure compliance with regulatory standards, enhancing product quality, and leading continuous process improvement across the organization. Critical capabilities and experiences include strategic risk governance, stakeholder engagement, process excellence, risk management, and people management. The Director will enable standardization for excellence, efficient and effective leverage of centralized services, drive end-to-end BU line of sight to risk areas, cross BU risk sharing and deployment of improvement strategies. Key Responsibilities: Leadership & Strategy:
Directly responsible and accountable for supervision and development of direct reports. Develop and implement an integrated bioresearch quality strategy that aligns proactive risk management and MedTech organizational goals to enable process optimization and innovation. Lead the quality process management team to promote a culture of quality and continuous improvement. Strategic oversight of activities and functions responsible for providing centralized visibility and reporting on risk data reporting. Regulatory Compliance:
Ensure MedTech R&D Quality Bioresearch procedures comply with industry regulations (e.g., FDA, ISO) and internal policies. Bioresearch Quality Process Management:
Design and optimize scope of Bioresearch R&D Quality processes and drive risk insights, including Clinical Risk Management, Bioresearch Audits, NC/CAPA/Escalation through cross-functional collaboration within R&D Quality MedTech Bioresearch, MedTech Q&C functions, Subject Matter Experts and cross functional business partners. Identify areas of improvement and implement best practices including business development due diligence, clinical risk management, integration and inspections for bioresearch quality. Responsible for driving innovation and continuous improvement in portfolio bioresearch quality activity processes. Data Analytics, Reporting & Governance:
Establish and utilize data analytics through digitalization and AI to monitor quality metrics and drive decision-making of bioresearch quality activities. Prepare reports for senior management on quality performance and improvement initiatives. Enable cross Business Unit governance of bioresearch quality risks, mitigations and sharing of best practices. Training & Development:
Oversee the development of training programs for staff on bioresearch quality processes and compliance requirements to ensure a knowledgeable workforce. Establish and enable sharing of best practices through communities of practice across MedTech Businesses. Risk Management:
Establish potential risks in pre-clinical/clinical/Med Safety/PV quality systems and processes and implement mitigation strategies to minimize impact and drive innovation. Responsible for owning the process to provide centralized insights on risks, on portfolio quality activities, and reporting processes. Stakeholder Management:
Establish and maintain strong relationships with internal and external stakeholders to advocate for Bioresearch quality and process excellence. Portfolio & Budget Management:
Establish process for visibility to activity drivers and portfolio. Ownership of creating and maintaining central visibility for budget planning, prioritization and value creation. Qualifications Education: Bachelor's or equivalent university degree is required Experience and Skills: Required: A minimum of 10 years working in regulated environments Ability to effectively apply project management tools and lean methodologies when leading projects and programs Excellent leadership skills, self-starting/motivated with highly developed interpersonal and teamwork skills Ability to quickly process and communicate complex information and make critical decisions with limited information Experience with strategy execution and implementation, and reporting to executive level leadership Experience influencing or persuading others to accept new ideas, approaches, or concepts or gains alignment on divergent issues with limited guidance Experience with Integrations, Clinical quality processes and procedures and systems, including remediation efforts Established trusted leadership, anticipating business needs and proactively takes actions; leverages relationships; develops strategic alliances Big picture orientation with attention to detail and results oriented Ability to work in a matrix and multi-cultural environment Preferred: Leadership in digitalization initiatives and AI application/products Established expertise or experience in process excellence or design, clinical risk management, and process management Other: Travel availability up to 20% (domestic and international) is required English language proficiency (written and verbal) is required Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills: Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Inclusive Leadership, Internal Auditing, ISO 9001, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Processes, Quality Standards, Quality Validation, Resource Planning, Risk Management, Standard Operating Procedure (SOP), Tactical Planning
The anticipated base pay range for this position is : $150,000.00 - $258,750.00
For Bay Area: $172,000.00 - $297,850.00
Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits]]>
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
We provide an inclusive work environment where each person is considered as an individual.
At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function: Quality
Job Sub
Function: Multi-Family Quality
Job Category: People Leader
All Job Posting Locations: Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, Miami, Florida, United States of America, Mountain View, California, United States of America, New Brunswick, New Jersey, United States of America, Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Santa Clara, California, United States of America
Job Description: Johnson & Johnson is recruiting for a
Director, Bioresearch Quality Process Management , located at one of the identified Johnson & Johnson Medtech sites:
New Brunswick, NJ; Mountain View, CA; Cincinnati, OH; Jacksonville, FL; Miami, FL; Raritan, NJ; Irvine, CA; Palm Beach Gardens, FL; Santa Clara, CA
and
Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Director, Bioresearch Quality Process Management, is a highly experienced and strategic leader accountable to spearhead Bioresearch related quality process enhancements and governance. In partnership with MedTech Bioresearch R&D Quality functional leads and MedTech Q&C Centers of Excellence, this critical role is instrumental in enabling transparency of bioresearch quality risks across MedTech Business Units, with fit for purpose and standardized quality processes & approaches in support of pre-clinical, clinical, medical safety and pharmacovigilance quality program activities. The role will also ensure compliance with regulatory standards, enhancing product quality, and leading continuous process improvement across the organization. Critical capabilities and experiences include strategic risk governance, stakeholder engagement, process excellence, risk management, and people management. The Director will enable standardization for excellence, efficient and effective leverage of centralized services, drive end-to-end BU line of sight to risk areas, cross BU risk sharing and deployment of improvement strategies. Key Responsibilities: Leadership & Strategy:
Directly responsible and accountable for supervision and development of direct reports. Develop and implement an integrated bioresearch quality strategy that aligns proactive risk management and MedTech organizational goals to enable process optimization and innovation. Lead the quality process management team to promote a culture of quality and continuous improvement. Strategic oversight of activities and functions responsible for providing centralized visibility and reporting on risk data reporting. Regulatory Compliance:
Ensure MedTech R&D Quality Bioresearch procedures comply with industry regulations (e.g., FDA, ISO) and internal policies. Bioresearch Quality Process Management:
Design and optimize scope of Bioresearch R&D Quality processes and drive risk insights, including Clinical Risk Management, Bioresearch Audits, NC/CAPA/Escalation through cross-functional collaboration within R&D Quality MedTech Bioresearch, MedTech Q&C functions, Subject Matter Experts and cross functional business partners. Identify areas of improvement and implement best practices including business development due diligence, clinical risk management, integration and inspections for bioresearch quality. Responsible for driving innovation and continuous improvement in portfolio bioresearch quality activity processes. Data Analytics, Reporting & Governance:
Establish and utilize data analytics through digitalization and AI to monitor quality metrics and drive decision-making of bioresearch quality activities. Prepare reports for senior management on quality performance and improvement initiatives. Enable cross Business Unit governance of bioresearch quality risks, mitigations and sharing of best practices. Training & Development:
Oversee the development of training programs for staff on bioresearch quality processes and compliance requirements to ensure a knowledgeable workforce. Establish and enable sharing of best practices through communities of practice across MedTech Businesses. Risk Management:
Establish potential risks in pre-clinical/clinical/Med Safety/PV quality systems and processes and implement mitigation strategies to minimize impact and drive innovation. Responsible for owning the process to provide centralized insights on risks, on portfolio quality activities, and reporting processes. Stakeholder Management:
Establish and maintain strong relationships with internal and external stakeholders to advocate for Bioresearch quality and process excellence. Portfolio & Budget Management:
Establish process for visibility to activity drivers and portfolio. Ownership of creating and maintaining central visibility for budget planning, prioritization and value creation. Qualifications Education: Bachelor's or equivalent university degree is required Experience and Skills: Required: A minimum of 10 years working in regulated environments Ability to effectively apply project management tools and lean methodologies when leading projects and programs Excellent leadership skills, self-starting/motivated with highly developed interpersonal and teamwork skills Ability to quickly process and communicate complex information and make critical decisions with limited information Experience with strategy execution and implementation, and reporting to executive level leadership Experience influencing or persuading others to accept new ideas, approaches, or concepts or gains alignment on divergent issues with limited guidance Experience with Integrations, Clinical quality processes and procedures and systems, including remediation efforts Established trusted leadership, anticipating business needs and proactively takes actions; leverages relationships; develops strategic alliances Big picture orientation with attention to detail and results oriented Ability to work in a matrix and multi-cultural environment Preferred: Leadership in digitalization initiatives and AI application/products Established expertise or experience in process excellence or design, clinical risk management, and process management Other: Travel availability up to 20% (domestic and international) is required English language proficiency (written and verbal) is required Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills: Budget Management, Compliance Management, Corrective and Preventive Action (CAPA), Developing Others, Inclusive Leadership, Internal Auditing, ISO 9001, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Processes, Quality Standards, Quality Validation, Resource Planning, Risk Management, Standard Operating Procedure (SOP), Tactical Planning
The anticipated base pay range for this position is : $150,000.00 - $258,750.00
For Bay Area: $172,000.00 - $297,850.00
Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits]]>