Manager, Quality Assurance

Role: Quality Assurance Manager overseeing drug product quality and compliance within a biopharma manufacturing setting. Objectives include ensuring GMP compliance, product quality, and proper implementation of quality systems. Responsibilities encompass approving/rejecting standards and products, conducting investigations, monitoring GMP adherence, evaluating batch records, and supervising staff. Requirements: Bachelor’s in a scientific discipline, at least 8 years of QA experience in pharmaceutical manufacturing, extensive knowledge of US and European GMP requirements, experience with technology transfer, validation, and quality systems. Preferred: experience with parenteral dosage forms, strong communication skills, and leadership abilities. HighValue: expertise in drug product GMP, quality system implementation, validation, regulatory compliance from GLP to commercial manufacturing, and experience with US and EU guidelines. Collaboration involves cross-functional teams, management, and external audits. Work setup is implied to be in a manufacturing facility with a focus on leadership, compliance, and continuous improvement.