Director, Quality Product Strategy (Devices)
MSD, Rahway, NJ, United States
Overview
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 for our inline portfolio, coordination with the Development and Commercialization Team (DCT) and Quality Working Group Leader. Responsibilities
Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises, including 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. Acts as a quality designee for global product quality as needed. Ensures prioritization, progress, and escalation of quality related strategic goals through periodic reviews and dashboards across products and manufacturing/testing sites in the network. Leads and/or participates in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across the Research & Development Division and the Manufacturing Division. Reviews and approves 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 meetings for the franchise, where applicable, and serves as the Quality Representative to DCT/VCMT and associated working groups. Collaborates 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 gaps in QMS requirements critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement of QMS documents. Tracks metrics (change control, complaint, etc.) for the franchise. Evaluates the franchise's Annual Product Review for supply chain trends and escalates risks as necessary. Participates and escalates issues/risk to the Quality sponsors and via IRM as required and supports development of Analytical Siting decisions. Monitors and mitigates franchise quality risks. Participates in inspections as required and champions Permanent Inspection Readiness (PIR) for the product program. Qualifications and Skills
Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics with minimum 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 such as 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 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. Networking/Inclusion: Building partnerships 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; communicating effectively, clearly and concisely; listening actively. Required and Preferred Skills
Analytical Thinking Collaboration Communication Cross-Functional Work Global Supply Chain Strategy Inspection Readiness Medical Devices Product Quality Quality Assurance (QA) Quality Mindset Company Information and Application
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 click here if you need an accommodation during the application or hiring process. 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. Salary and Benefits
The salary range for this role is $173,200.00 - $272,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, 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 website. Posting and Compliance
You can apply for this role through the company website or via the Workday Jobs Hub if you are a current employee. The application deadline is stated on this posting. San Francisco Residents Only: we will consider qualified applicants with arrest and conviction records per the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: we will consider all qualified applicants in compliance with applicable state and local laws. This posting ends on 04/11/2026. Travel requirements: 10%. Hybrid work model: 3 days on-site per week in the US, with Friday remote, unless business critical tasks require on-site presence. Regular (non-remote) roles may have different requirements. End Date: 04/11/2026. Requisition ID
R390606
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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 for our inline portfolio, coordination with the Development and Commercialization Team (DCT) and Quality Working Group Leader. Responsibilities
Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises, including 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. Acts as a quality designee for global product quality as needed. Ensures prioritization, progress, and escalation of quality related strategic goals through periodic reviews and dashboards across products and manufacturing/testing sites in the network. Leads and/or participates in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across the Research & Development Division and the Manufacturing Division. Reviews and approves 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 meetings for the franchise, where applicable, and serves as the Quality Representative to DCT/VCMT and associated working groups. Collaborates 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 gaps in QMS requirements critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement of QMS documents. Tracks metrics (change control, complaint, etc.) for the franchise. Evaluates the franchise's Annual Product Review for supply chain trends and escalates risks as necessary. Participates and escalates issues/risk to the Quality sponsors and via IRM as required and supports development of Analytical Siting decisions. Monitors and mitigates franchise quality risks. Participates in inspections as required and champions Permanent Inspection Readiness (PIR) for the product program. Qualifications and Skills
Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics with minimum 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 such as 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 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. Networking/Inclusion: Building partnerships 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; communicating effectively, clearly and concisely; listening actively. Required and Preferred Skills
Analytical Thinking Collaboration Communication Cross-Functional Work Global Supply Chain Strategy Inspection Readiness Medical Devices Product Quality Quality Assurance (QA) Quality Mindset Company Information and Application
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 click here if you need an accommodation during the application or hiring process. 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. Salary and Benefits
The salary range for this role is $173,200.00 - $272,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, 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 website. Posting and Compliance
You can apply for this role through the company website or via the Workday Jobs Hub if you are a current employee. The application deadline is stated on this posting. San Francisco Residents Only: we will consider qualified applicants with arrest and conviction records per the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: we will consider all qualified applicants in compliance with applicable state and local laws. This posting ends on 04/11/2026. Travel requirements: 10%. Hybrid work model: 3 days on-site per week in the US, with Friday remote, unless business critical tasks require on-site presence. Regular (non-remote) roles may have different requirements. End Date: 04/11/2026. Requisition ID
R390606
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