Director, Quality Product Strategy (Small Molecule)
Merck, Rahway, NJ, United States
Overview
The Director, Quality Product Strategy (Small Molecule) supports the end-to-end pharmaceutical product strategy in our manufacturing and testing network. Responsibilities include developing and executing a robust quality strategy for products supporting pipeline launches and/or uninterrupted supply of commercial products. This role participates as a Value Chain Management Team (VCMT) member, supports late-stage pipeline Quality activities and inline quality issues, sponsors projects, and leads strategic network changes for the inline portfolio. It coordinates with the Development and Commercialization Team (DCT) and the Quality Working Group Leader. Primary Responsibilities
Lead the development and oversight of Product Quality Strategic elements for the pharmaceutical franchises, including short- and long-term goals aligned with the DCT/VCMT/Platform Councils/Product Councils. Include inspection readiness, launch readiness for pipeline products, testing and quality strategies, risk mitigation, issue resolution, network expansion, and supply chain robustness at the global franchise level. Serve as a quality designee for global product quality as needed. Prioritize, track progress, and escalate quality-related strategic goals through periodic reviews and dashboards across products and manufacturing/testing sites. Lead and/or participate in executing VCMT/DCT-aligned strategic goals with stakeholders across Research & Development and Manufacturing divisions. Review and approve franchise-level documentation as appropriate, including comparability plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, control strategies, franchise-level protocols/reports, filing/license submissions, regulatory observation responses, change controls, site and multi-site investigations, where appropriate. Lead/coordinate Quality Working Group meetings for the franchise and serve as the Quality Representative to DCT/VCMT and associated working groups. Collaborate with Quality leads to resolve supply chain quality issues. Collaborate with QMS Chapter leads and document owners to define, refine, and standardize quality requirements. Identify gaps in QMS requirements critical for consistent interpretation of regulations related to products to drive standardization and continuous improvement of QMS documents. Track metrics (e.g., change control, complaints) for the franchise. Evaluate the franchise’s Annual Product Review for supply chain trends and escalate risks as necessary. Participate in risk escalation to Quality sponsors via IRM as required and support Analytical Siting decisions when needed. Monitor and mitigate franchise quality risks. Participate in inspections as required and champion Permanent Inspection Readiness (PIR) for the product program. Qualifications and Requirements
Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics and a minimum of twelve (12) years of experience, including quality oversight roles with 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 in external-facing written and verbal communications. Proven success leading multi-functional teams driving continuous improvement and executing strategic actions across a network (multiple groups/sites/functions). Approximately 10% travel. Entrepreneurship/Innovation: addressing patient/customer/organizational needs with creative solutions and action. Decision Making/Influence: problem identification, data analysis, solution evaluation, timely decision-making with stakeholder buy-in. Growth/Development/Change: applying new knowledge on the job and adapting to major changes in work or environment. Networking/Inclusion: building partnerships and working effectively across cultures and backgrounds. Execution Excellence/Ownership/Inspiration: high standards of performance, proactive communication, and clear, concise messaging for stakeholders. Skills and Domains
Required Skills: Active Pharmaceutical Ingredients (API), Collaboration, Drug Product Manufacturing, Packaging, Pharmaceutical Drugs, Pharmaceutical Products, Product Quality, Product Quality Assurance, Quality Oversight, Small Molecule Drug Development, Small Molecule Drugs, Small Molecules. Preferred and Other Details
Current Employees apply HERE. Current Contingent Workers apply HERE. US and Puerto Rico Residents Only: Our company is committed to inclusion. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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 legally protected characteristics. As a Federal Contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about rights under U.S. EEO laws, visit: EEOC Know Your Rights; EEOC GINA Supplement. We embrace diverse experiences and backgrounds and encourage collaboration across perspectives to drive innovation. Learn more about your rights, including state-specific acts. Compensation and Work Model
U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will work a hybrid model with three on-site days per week (Mon-Thurs) and remote Fridays, subject to site needs. This model does not apply to field-based, facility-based, manufacturing-based, or on-site roles, or roles under collective bargaining agreements unless otherwise stated. Salary range: $173,200.00 – $272,600.00. The range reflects good faith estimates at posting time and depends on factors such as education, experience, location, and business needs. Eligible for annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision, retirement, paid holidays, vacation, and sick days. More information at https://jobs.merck.com/us/en/compensation-and-benefits. Application: Apply at https://jobs.merck.com/us/en or via the Workday Jobs Hub if you are a current employee. The posting end date is listed in the job posting. Other notes: San Francisco residents: we consider qualified applicants with arrest/conviction records as required by the San Francisco Fair Chance Ordinance. Los Angeles residents: we comply with applicable laws including the City of Los Angeles Fair Chance Initiative. Travel: 10%. Relocation: No. VISA Sponsorship: No. Job Posting End Date: 04/11/2026.
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The Director, Quality Product Strategy (Small Molecule) supports the end-to-end pharmaceutical product strategy in our manufacturing and testing network. Responsibilities include developing and executing a robust quality strategy for products supporting pipeline launches and/or uninterrupted supply of commercial products. This role participates as a Value Chain Management Team (VCMT) member, supports late-stage pipeline Quality activities and inline quality issues, sponsors projects, and leads strategic network changes for the inline portfolio. It coordinates with the Development and Commercialization Team (DCT) and the Quality Working Group Leader. Primary Responsibilities
Lead the development and oversight of Product Quality Strategic elements for the pharmaceutical franchises, including short- and long-term goals aligned with the DCT/VCMT/Platform Councils/Product Councils. Include inspection readiness, launch readiness for pipeline products, testing and quality strategies, risk mitigation, issue resolution, network expansion, and supply chain robustness at the global franchise level. Serve as a quality designee for global product quality as needed. Prioritize, track progress, and escalate quality-related strategic goals through periodic reviews and dashboards across products and manufacturing/testing sites. Lead and/or participate in executing VCMT/DCT-aligned strategic goals with stakeholders across Research & Development and Manufacturing divisions. Review and approve franchise-level documentation as appropriate, including comparability plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, control strategies, franchise-level protocols/reports, filing/license submissions, regulatory observation responses, change controls, site and multi-site investigations, where appropriate. Lead/coordinate Quality Working Group meetings for the franchise and serve as the Quality Representative to DCT/VCMT and associated working groups. Collaborate with Quality leads to resolve supply chain quality issues. Collaborate with QMS Chapter leads and document owners to define, refine, and standardize quality requirements. Identify gaps in QMS requirements critical for consistent interpretation of regulations related to products to drive standardization and continuous improvement of QMS documents. Track metrics (e.g., change control, complaints) for the franchise. Evaluate the franchise’s Annual Product Review for supply chain trends and escalate risks as necessary. Participate in risk escalation to Quality sponsors via IRM as required and support Analytical Siting decisions when needed. Monitor and mitigate franchise quality risks. Participate in inspections as required and champion Permanent Inspection Readiness (PIR) for the product program. Qualifications and Requirements
Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics and a minimum of twelve (12) years of experience, including quality oversight roles with 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 in external-facing written and verbal communications. Proven success leading multi-functional teams driving continuous improvement and executing strategic actions across a network (multiple groups/sites/functions). Approximately 10% travel. Entrepreneurship/Innovation: addressing patient/customer/organizational needs with creative solutions and action. Decision Making/Influence: problem identification, data analysis, solution evaluation, timely decision-making with stakeholder buy-in. Growth/Development/Change: applying new knowledge on the job and adapting to major changes in work or environment. Networking/Inclusion: building partnerships and working effectively across cultures and backgrounds. Execution Excellence/Ownership/Inspiration: high standards of performance, proactive communication, and clear, concise messaging for stakeholders. Skills and Domains
Required Skills: Active Pharmaceutical Ingredients (API), Collaboration, Drug Product Manufacturing, Packaging, Pharmaceutical Drugs, Pharmaceutical Products, Product Quality, Product Quality Assurance, Quality Oversight, Small Molecule Drug Development, Small Molecule Drugs, Small Molecules. Preferred and Other Details
Current Employees apply HERE. Current Contingent Workers apply HERE. US and Puerto Rico Residents Only: Our company is committed to inclusion. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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 legally protected characteristics. As a Federal Contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about rights under U.S. EEO laws, visit: EEOC Know Your Rights; EEOC GINA Supplement. We embrace diverse experiences and backgrounds and encourage collaboration across perspectives to drive innovation. Learn more about your rights, including state-specific acts. Compensation and Work Model
U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will work a hybrid model with three on-site days per week (Mon-Thurs) and remote Fridays, subject to site needs. This model does not apply to field-based, facility-based, manufacturing-based, or on-site roles, or roles under collective bargaining agreements unless otherwise stated. Salary range: $173,200.00 – $272,600.00. The range reflects good faith estimates at posting time and depends on factors such as education, experience, location, and business needs. Eligible for annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision, retirement, paid holidays, vacation, and sick days. More information at https://jobs.merck.com/us/en/compensation-and-benefits. Application: Apply at https://jobs.merck.com/us/en or via the Workday Jobs Hub if you are a current employee. The posting end date is listed in the job posting. Other notes: San Francisco residents: we consider qualified applicants with arrest/conviction records as required by the San Francisco Fair Chance Ordinance. Los Angeles residents: we comply with applicable laws including the City of Los Angeles Fair Chance Initiative. Travel: 10%. Relocation: No. VISA Sponsorship: No. Job Posting End Date: 04/11/2026.
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