GMP Associate Director

A clinical-stage biotechnology company in South San Francisco is seeking an Associate Director of CGMP Quality Assurance. This role reports directly to the Head of Quality and plays a crucial part in managing external vendors and CDMOs, while contributing to the development and maintenance of quality systems. The ideal candidate will have deep expertise in CGMP regulations, a proactive approach to quality management, and the ability to foster a culture of ethics and integrity.Key Responsibilities:Serve as the technical expert on CGMP regulations for manufacturing, testing, and controls.Review and approve manufacturing, packaging, and labeling documents for drug substances and products within established timelines.Lead external quality activities including batch record reviews, analytical method validations, tech transfers, deviations, quality agreements, supplier qualifications, and audits.Participate in CDMO team meetings, offering quality feedback and collaborating on complex investigations for the global product network.Collect, review, and analyze data for internal and external quality metrics.Provide guidance and assessments for change controls and CAPAs.Implement CGMP and GLP activities in accordance with internal procedures and regulatory standards.Participate in quality system and product review meetings, ensuring data integrity and compliance.Represent the Quality department in project teams, health authority inspections, and supplier/CDMO meetings.Collaborate with the Quality Person (QP) to develop and approve key documents.Gain hands-on experience with GCP-focused projects, including potential auditing activities.Promote a strong quality mindset and culture of collaboration aligned with company values.Qualifications:Strong decision-making skills in complex supply, compliance, technical, and regulatory environments.Hands-on experience in manufacturing, analytical testing, and development.Proven track record working with suppliers and CDMOs.Expertise in implementing and managing Quality Management Systems, both paper-based and electronic (Celito EDMS preferred).In-depth knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidelines.Experience in developing and maintaining compliant Quality Management Systems.Excellent verbal and written communication skills.Strong collaborative, analytical, and problem-solving abilities.Ability to work independently, prioritize tasks, and meet deadlines.Experience working in cross-functional teams.Willingness to travel up to 10%.Education & Experience:Bachelor's or advanced degree in Biology, Chemistry, Chemical Engineering, or a related scientific field.Minimum of 5 years of CGMP Quality Assurance experience.Knowledge of clinical development through to commercial stages is desirable, particularly Phase II/III to commercial.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionScience, Accounting/Auditing, and ResearchIndustriesBiotechnology Research and Pharmaceutical Manufacturing#J-18808-Ljbffr

Created: 2025-03-05