Director, Quality Assurance – Value Chain Management
Merck
9 hours ago
Remote
United States
Operations
Step into a key Quality leadership role overseeing the end-to-end quality program for an assigned product value chain in antibody drug conjugates. Core member of the Value Chain Management Team, partnering across functions to ensure a reliable supply of high-quality products throughout their commercial lifecycle.
Responsibilities
- 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; share best practices across sites.
- Stay current with regulatory requirements; support/lead inspections; drive inspection readiness.
- Provide quality leadership to product focus teams and working groups.
- Lead quality communications across the network, including meetings, updates, and escalation of issues/risks.
- Support analytical siting strategies and broader value-chain projects with quality input and follow-through.
- Track and interpret change control, complaints, and quality performance data to identify trends.
- Review Annual Product Reviews and post-marketing product reviews to assess and communicate risks.
- Monitor, report, and mitigate quality and supply chain risks.
Qualifications/Required Skills
- At least 10 years of pharmaceutical industry experience, including leadership experience.
- Strong project management skills; ability to drive complex initiatives to completion.
- Clear communication (written/verbal); leadership and stakeholder management.
- Degree/postgraduate in a relevant Science, Pharmacy, or Engineering field.
- Proven ability to drive change/improvement; commitment to continuous improvement.
- Track record in team environments (e.g., Six Sigma).
Required/Additional
- Willingness to travel 10–15% for assignments outside primary location.
- Role can be based anywhere in the US and Europe.
Required Skills
- Antibody Drug Conjugates (ADC), Collaboration, Communication, Continuous Improvement, Leadership, Program Management, Project Management, Quality Compliance, Risk Analysis, Stakeholder Management, Strategic Thinking.
Preferred Skills
- Quality and/or technology experience in vaccines or large molecule products; continuous improvement or analytical science experience.
Application
- Apply today.
Responsibilities
- 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; share best practices across sites.
- Stay current with regulatory requirements; support/lead inspections; drive inspection readiness.
- Provide quality leadership to product focus teams and working groups.
- Lead quality communications across the network, including meetings, updates, and escalation of issues/risks.
- Support analytical siting strategies and broader value-chain projects with quality input and follow-through.
- Track and interpret change control, complaints, and quality performance data to identify trends.
- Review Annual Product Reviews and post-marketing product reviews to assess and communicate risks.
- Monitor, report, and mitigate quality and supply chain risks.
Qualifications/Required Skills
- At least 10 years of pharmaceutical industry experience, including leadership experience.
- Strong project management skills; ability to drive complex initiatives to completion.
- Clear communication (written/verbal); leadership and stakeholder management.
- Degree/postgraduate in a relevant Science, Pharmacy, or Engineering field.
- Proven ability to drive change/improvement; commitment to continuous improvement.
- Track record in team environments (e.g., Six Sigma).
Required/Additional
- Willingness to travel 10–15% for assignments outside primary location.
- Role can be based anywhere in the US and Europe.
Required Skills
- Antibody Drug Conjugates (ADC), Collaboration, Communication, Continuous Improvement, Leadership, Program Management, Project Management, Quality Compliance, Risk Analysis, Stakeholder Management, Strategic Thinking.
Preferred Skills
- Quality and/or technology experience in vaccines or large molecule products; continuous improvement or analytical science experience.
Application
- Apply today.