Director, Quality Product Strategy (Devices)
Merck, Durham, NC, United States
Overview
Job Description The
Director, Quality Product Strategy (Devices)
supports the end-to-end pharmaceutical product strategy in our manufacturing and testing network. Ensures development and execution of a robust quality strategy for products supporting launch of the pipeline and/or uninterrupted supply of commercial products. Scope of responsibilities includes value chain management team (VCMT) member, franchise support of late stage pipeline Quality activities as well as inline quality related issues, sponsored project support and strategic network changes (e.g. expansion and supply chain robustness) for our inline portfolio, coordination with the Development and Commercialization Team (DCT) and Quality Working Group Leader.
Primary Activities
Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises that includes short and long-term goals for the product franchise in alignment with the DCT/VCMT/Platform Councils/Product Councils. Strategic elements include inspection and launch readiness for pipeline products and testing and quality strategies (product analytical strategy), risk mitigation, issue resolution, network expansion, supply chain robustness at the global franchise level. Act as a quality designee for global product quality as needed. Ensures prioritization, progress, and escalation, as appropriate, of quality related strategic goals (including strategy, efficiency and compliance related items) through periodic reviews and dashboard across products and manufacturing/testing sites across the network. Lead and/or participate in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across our Research & Development Division and our Manufacturing Division. Review and approve, as appropriate, franchise level documentation including but not limited to: Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, Control Strategies, franchise level protocols/reports, filing/license submissions, franchise level regulatory observation responses, RTQs, franchise level change control, site and multi-site investigations, where appropriate. Leads/coordinates Quality Working Group meeting for the franchise, where applicable and serves as the Quality Representative to DCT/VCMT and associated working groups, where applicable. Collaborate with Quality leads to resolve supply chain quality issues. Collaborates with QMS Chapter leads and document owners to define, refine and standardize quality requirements. Identifies any gaps in QMS requirements that are critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement to QMS documents. Track metrics (change control, complaint, etc.) for the franchise. Evaluate the franchise's Annual Product Review for supply chain trends and escalate risks as necessary. Actively participate and escalate issues/risk to the Quality sponsors and via IRM as required and identify need for and support development of Analytical Siting decisions. Monitor and mitigate franchise Quality risks. Participate in inspections as required and champion Permanent Inspection Readiness (PIR) for the product program.
Qualifications
Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics with minimum of twelve (12) years of experience including quality oversight roles including technical elements or technical operations roles. Minimum of 2 years direct experience with supply chain strategy or technical elements (e.g. change controls, investigations, process documentation (e.g. protocols, CPV, etc.), preferably with small molecule products. Demonstrated skills for external facing communications in written and verbal form. Demonstrated success leading multi-functional teams driving continuous improvement and execution of strategic actions across a network (i.e. multiple groups/sites/functions). Travel is approximately 10%. Entrepreneurship/Innovation: Meeting patient and customer and organization’s needs by confronting difficult issues, offering creative alternatives and taking action. Decision Making/Influence: Identifying and understanding problems; gathering, analyzing and interpreting information, establishing decision criteria, and identifying alternatives. Making timely decisions using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes. Growth/Development/Change: Using new knowledge and skills on the job and learning through application. Modifying behavior based on self-awareness to improve impact and adaptability for major changes in work or environment (e.g., people, processes, structure or culture), trying new approaches. Networking/Inclusion: Building partnerships; developing and leveraging relationships within and across work groups to achieve results. Working effectively across cultures, interpersonal styles, perspectives, motivations or backgrounds. Execution Excellence/Ownership/Inspiration: Being proactive and setting high standards of performance for self and others; completing assignments or tasks; communicating effectively, clearly and concisely helping stakeholders understand and retain the message; listening actively.
Required Skills
Analytical Thinking, Collaboration, Communication, Cross-Functional Work, Global Supply Chain Strategy, Inspection Readiness, Medical Devices, Product Quality, Quality Assurance (QA), Quality Mindset
Preferred Skills
Current Employees apply here Current Contingent Workers apply here
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please review accommodations during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the following resources: EEOC Know Your Rights; EEOC GINA Supplement.
We are proud to be a company that embraces diversity and inclusion. Learn more about your rights, including under California, Colorado and other US State Acts.
U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work model consisting of three total days on-site per week, with specific days varying by site. This model does not apply to field-based, facility-based, manufacturing-based, or research-based positions located at a Company site, roles with a collective-bargaining agreement (unless the agreement provides for hybrid work), or roles designated as remote.
The salary range for this role is $173,200.00 - $272,600.00. The salary will depend on factors including education, qualifications, certifications, experience, skills, location, and business needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive benefits package, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at the company compensation and benefits page.
You can apply for this role through the company careers site (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only:
We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only:
We will consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable laws.
Search Firm Representatives Please Read Carefully
We do not accept unsolicited assistance from search firms for employment opportunities. CVs/resumes submitted without a valid written search agreement will be the property of the company. No fee will be paid in the event a candidate is hired as a result of an agency referral without an agreement.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
04/11/2026
*A job posting is effective until 11:59:59PM on the day before the listed job posting end date. Please ensure you apply to a job posting no later than the day before the job posting end date.*
#J-18808-Ljbffr
Job Description The
Director, Quality Product Strategy (Devices)
supports the end-to-end pharmaceutical product strategy in our manufacturing and testing network. Ensures development and execution of a robust quality strategy for products supporting launch of the pipeline and/or uninterrupted supply of commercial products. Scope of responsibilities includes value chain management team (VCMT) member, franchise support of late stage pipeline Quality activities as well as inline quality related issues, sponsored project support and strategic network changes (e.g. expansion and supply chain robustness) for our inline portfolio, coordination with the Development and Commercialization Team (DCT) and Quality Working Group Leader.
Primary Activities
Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises that includes short and long-term goals for the product franchise in alignment with the DCT/VCMT/Platform Councils/Product Councils. Strategic elements include inspection and launch readiness for pipeline products and testing and quality strategies (product analytical strategy), risk mitigation, issue resolution, network expansion, supply chain robustness at the global franchise level. Act as a quality designee for global product quality as needed. Ensures prioritization, progress, and escalation, as appropriate, of quality related strategic goals (including strategy, efficiency and compliance related items) through periodic reviews and dashboard across products and manufacturing/testing sites across the network. Lead and/or participate in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across our Research & Development Division and our Manufacturing Division. Review and approve, as appropriate, franchise level documentation including but not limited to: Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, Control Strategies, franchise level protocols/reports, filing/license submissions, franchise level regulatory observation responses, RTQs, franchise level change control, site and multi-site investigations, where appropriate. Leads/coordinates Quality Working Group meeting for the franchise, where applicable and serves as the Quality Representative to DCT/VCMT and associated working groups, where applicable. Collaborate with Quality leads to resolve supply chain quality issues. Collaborates with QMS Chapter leads and document owners to define, refine and standardize quality requirements. Identifies any gaps in QMS requirements that are critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement to QMS documents. Track metrics (change control, complaint, etc.) for the franchise. Evaluate the franchise's Annual Product Review for supply chain trends and escalate risks as necessary. Actively participate and escalate issues/risk to the Quality sponsors and via IRM as required and identify need for and support development of Analytical Siting decisions. Monitor and mitigate franchise Quality risks. Participate in inspections as required and champion Permanent Inspection Readiness (PIR) for the product program.
Qualifications
Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics with minimum of twelve (12) years of experience including quality oversight roles including technical elements or technical operations roles. Minimum of 2 years direct experience with supply chain strategy or technical elements (e.g. change controls, investigations, process documentation (e.g. protocols, CPV, etc.), preferably with small molecule products. Demonstrated skills for external facing communications in written and verbal form. Demonstrated success leading multi-functional teams driving continuous improvement and execution of strategic actions across a network (i.e. multiple groups/sites/functions). Travel is approximately 10%. Entrepreneurship/Innovation: Meeting patient and customer and organization’s needs by confronting difficult issues, offering creative alternatives and taking action. Decision Making/Influence: Identifying and understanding problems; gathering, analyzing and interpreting information, establishing decision criteria, and identifying alternatives. Making timely decisions using effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes. Growth/Development/Change: Using new knowledge and skills on the job and learning through application. Modifying behavior based on self-awareness to improve impact and adaptability for major changes in work or environment (e.g., people, processes, structure or culture), trying new approaches. Networking/Inclusion: Building partnerships; developing and leveraging relationships within and across work groups to achieve results. Working effectively across cultures, interpersonal styles, perspectives, motivations or backgrounds. Execution Excellence/Ownership/Inspiration: Being proactive and setting high standards of performance for self and others; completing assignments or tasks; communicating effectively, clearly and concisely helping stakeholders understand and retain the message; listening actively.
Required Skills
Analytical Thinking, Collaboration, Communication, Cross-Functional Work, Global Supply Chain Strategy, Inspection Readiness, Medical Devices, Product Quality, Quality Assurance (QA), Quality Mindset
Preferred Skills
Current Employees apply here Current Contingent Workers apply here
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please review accommodations during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the following resources: EEOC Know Your Rights; EEOC GINA Supplement.
We are proud to be a company that embraces diversity and inclusion. Learn more about your rights, including under California, Colorado and other US State Acts.
U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work model consisting of three total days on-site per week, with specific days varying by site. This model does not apply to field-based, facility-based, manufacturing-based, or research-based positions located at a Company site, roles with a collective-bargaining agreement (unless the agreement provides for hybrid work), or roles designated as remote.
The salary range for this role is $173,200.00 - $272,600.00. The salary will depend on factors including education, qualifications, certifications, experience, skills, location, and business needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive benefits package, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at the company compensation and benefits page.
You can apply for this role through the company careers site (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only:
We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only:
We will consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable laws.
Search Firm Representatives Please Read Carefully
We do not accept unsolicited assistance from search firms for employment opportunities. CVs/resumes submitted without a valid written search agreement will be the property of the company. No fee will be paid in the event a candidate is hired as a result of an agency referral without an agreement.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
04/11/2026
*A job posting is effective until 11:59:59PM on the day before the listed job posting end date. Please ensure you apply to a job posting no later than the day before the job posting end date.*
#J-18808-Ljbffr