Associate Director, Third Party Quality Management Drug Product (Hybrid

at  MSD

JOB DESCRIPTION

The incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. The position will be heavily involved in close collaboration with the contractor quality and technical personnel and will partner with internal development teams on objectives utilizing external contractors including GMP qualification as well as the support of small and large molecule development programs.
Additional experience in drug substance manufacturing and medical device and/or combination products would be preferred.

PREFERRED EXPERIENCE:

• 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

EDUCATION MINIMUM REQUIREMENT:

• Bachelor’s degree in relevant area related to engineering, chemistry, or biology.
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TRAVEL REQUIREMENTS:

25%

Required Experience:

• Minimum of 5 years within pharmaceutical drug product manufacturing and 10 years overall within biopharmaceuticals.
• Planning and facilitating high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision.
• Providing project leadership in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment).
• Identifying trends and/or potential compliance gaps and proactively leading the resolution of issues affecting quality and efficiency.
• Interpreting complex regulatory requirements for various audiences, including source area management, and facilitating communication of these requirements across stakeholders

Activities that this position would be responsible for include:

• Leading overall quality relationships with contract manufacturing organizations,
• Negotiation of site and global Technical and Quality Agreements,
• Participating in contractor GMP audits as a Subject Matter Expert,
• Conduct of contractor “deep dive” quality assessments such in data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform,
• Supporting product development teams in outsourcing activities to enable our diverse pipeline
• Serving as the bridge for quality oversight between research and development and commercialization activities.
• Communicating, and serving as Quality spokesperson, on a variety of Quality or compliance-related issues.

Required Experience:

• Minimum of 5 years within pharmaceutical drug product manufacturing and 10 years overall within biopharmaceuticals.
• Planning and facilitating high risk and highly complex Quality-related process reviews and/or investigations under minimal supervision.
• Providing project leadership in area of expertise in own discipline (such as leading or facilitating teams involving source area representatives in a matrix management environment).
• Identifying trends and/or potential compliance gaps and proactively leading the resolution of issues affecting quality and efficiency.
• Interpreting complex regulatory requirements for various audiences, including source area management, and facilitating communication of these requirements across stakeholders.