Get AI-powered advice on this job and more exclusive features.This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.Base pay range$210,000.00/yr – $235,000.00/yrJob TitleDirector of GMP Quality AssuranceCompanyMeet Life SciencesLocationSouth San Francisco, CAResponsibilities:Oversee quality-related activities at CDMOs, including drug substance, drug product, packaging, and labeling.Manage quality systems at CDMOs, such as deviations, CAPAs, complaints, and batch release, ensuring compliance with standards.Conduct and review quality documentation, including SOPs, batch records, analytical methods, and regulatory submissions (BLA).Collaborate with CDMOs and internal teams to address quality issues, ensuring products meet quality standards and specifications.Monitor and report quality metrics, perform risk assessments, and maintain readiness for audits and regulatory inspections.Requirements:MS or BS degree in Biology, Chemistry, Chemical Engineering or a relevant discipline with 10 years of industry experience in a GMP-regulated biopharma/biotech environment.Experienced in supporting commercialization/BLA filing of protein-based molecules.Expertise in supplier/vendor quality management, biologics quality assurance, and regulatory compliance (FDA, ICH, GMP standards).Proven skills in GMP documentation, risk analysis, project management, and cross-functional collaboration.Strong problem-solving, communication, and organizational abilities, with a focus on adapting to dynamic environments.Contact:For a confidential discussion, please reach out to Amit at [email protected] levelDirectorEmployment typeFull-timeJob functionScience, Manufacturing, and Quality AssuranceReferrals increase your chances of interviewing at Meet Life Sciences by 2x. #J-18808-Ljbffr

Nice-to-have skills

• Project Management
• Cross-functional Collaboration
• Communication
• California, United States

Work experience

• IT Consultant

Languages

• English