Associate Director, Third Party Quality Management Drug Product (Hybrid)

Merck & Co. • West Point, PA

395d • $122,800 - $193,300 • Onsite

About The Position

The Associate Director of Third Party Quality Management for Drug Product is responsible for overseeing quality assurance processes related to contractors involved in GMP activities for clinical supplies. This role emphasizes collaboration with contractor quality teams and internal development groups to ensure compliance and quality standards are met throughout the drug product lifecycle, particularly for small and large molecule development programs.

Requirements

• Minimum of 5 years within pharmaceutical drug product manufacturing.
• 10 years overall experience within biopharmaceuticals.
• Experience in planning and facilitating high risk and complex Quality-related process reviews and investigations under minimal supervision.
• Project leadership experience in own discipline, leading or facilitating teams in a matrix management environment.
• Ability to identify trends and compliance gaps and proactively lead resolution of quality issues.
• Experience interpreting complex regulatory requirements for various audiences.

Nice To Haves

• Experience related to medical devices and combination products.
• Engagement with small and/or large molecule drug development programs from early phase through commercialization.
• Participation with contract manufacturing of clinical supplies.

Responsibilities

• Lead overall quality relationships with contract manufacturing organizations.
• Negotiate site and global Technical and Quality Agreements.
• Participate in contractor GMP audits as a Subject Matter Expert.
• Conduct contractor deep dive quality assessments focusing on data integrity and lead cross-functional contractor performance reviews as the quality lead.
• Support product development teams in outsourcing activities to enable a diverse pipeline.
• Serve as the bridge for quality oversight between research and development and commercialization activities.
• Communicate and serve as the Quality spokesperson on various Quality or compliance-related issues.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree