Overview
Associate Director, External Quality – Hybrid Jobs in Rahway, New Jersey, USA 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 API. 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.
Key Responsibilities:
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 substance (API) 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.
Preferred Experience:
Engagement with small molecule drug substance (API) 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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Title: Associate Director, External Quality – Hybrid
Company: MSD
Location: Rahway, New Jersey, USA
Category: Quality Assurance – QA/QC, Pharmaceutical
