Director, Quality Assurance - Value Chain Management
- Lead end-to-end quality oversight for the product program, ensuring compliance with procedures and regulations.
- Develop and maintain the Product Quality Strategy and Product Analytical Strategy in line with supply strategy.
- Partner with Quality, Regulatory, Technical, Supply Chain, and site Quality teams to align priorities and resolve issues.
- Strengthen and harmonize Quality Management Systems and ways of working, sharing best practices across sites.
- Stay current with regulatory requirements, support or lead inspections, and drive ongoing inspection readiness.
- Provide quality leadership to product focus teams, the Value Chain Management Team, and related working groups.
- Lead quality communications across the network, including meetings, updates, and escalation of issues and risks.
- Support analytical siting strategies and broader value-chain projects, ensuring quality input and follow-through.
- Track and interpret change control, complaints, and quality performance data to identify trends.
- Review Annual Product Reviews, evaluations, and post-marketing product reviews to assess and communicate risks.
- Monitor, report and mitigate quality and supply chain risks across the franchise.
- At least 10 years of experience in the pharmaceutical industry, including experience in a leadership role.
- Quality and/or technology experience in vaccines or large molecule products is an advantage.
- Experience in continuous improvement or analytical science is desirable.
- Strong project management skills and the ability to drive complex initiatives to completion.
- Clear, confident communication skills, both written and verbal.
- Experience leading multi-functional teams to deliver strategic outcomes.
- A degree or postgraduate qualification in a relevant Science, Pharmacy, or Engineering field.
- Proven ability to drive change and improvement initiatives.
- Strong leadership and stakeholder management skills, with the ability to influence at multiple levels.
- Commitment to continuous professional development and continuous improvement.
- A track record of success in team environments (for example, project teams, Six Sigma teams, or continuous improvement teams).
- Travel requirement:
- Willingness to travel 10-15% for assignments outside your primary location, including short-term travel as needed
- Location:
- The role can be based anywhere in the US and Europe
Antibody Drug Conjugates (ADC), Collaboration, Communication, Continuous Improvement, Leadership, Program Management, Project Management, Quality Compliance, Risk Analysis, Stakeholder Management, Strategic Thinking Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.- Employee Status:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Remote Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
N/A Job Posting End Date:
06/6/2026
*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. Requisition ID: R382595
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