Associate Director, Quality

Role: Associate Director Quality overseeing external supplier quality management for formulation, fill, finish, and packaging. Objectives include ensuring GMP compliance, supplier assessment, and driving process improvements within pharmaceutical supply chains. Responsibilities encompass managing supplier quality systems, reviewing cGMP documentation, conducting audits, and collaborating with cross-functional teams to resolve quality issues and support regulatory inspections. The role involves developing quality metrics, maintaining supplier relationships, and supporting compliance strategies. Qualifications: Bachelor's in Pharmacy, Biology, Chemistry, or Engineering; 10+ years in pharmaceutical quality assurance or operations; strong knowledge of cGMPs, industry standards, and supply chain quality systems. Preferred: Master's degree, experience in multi-site or Lean/Six Sigma, and familiarity with Quality Management Systems like Veeva Vault. High-value specifics: Focus on external supply, GMP compliance, collaboration with suppliers, and regulatory readiness; travel up to 25% nationally/internationally. The position is based in a hybrid setup.