Director Pharmacovigilance QA

1 week ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Meet Life SciencesSenior Client Partner | Master of Science in Pharmaceutical SciencesDirector, Pharmacovigilance Quality AssuranceRedwood City, CA | Hybrid (3 days on-site)Drive global PV compliance strategy at a fast-growing, clinical-stage biotechA pioneering, commercial-stage biotechnology company focused on developing treatments for serious endocrine, oncologic, neurologic, and metabolic disorders is seeking a Director of Pharmacovigilance Quality Assurance.With an expanding pipeline and a globally recognized product already on the market, this organization offers the chance to make a significant impact in a company on the rise.Key Responsibilities:Lead QA activities supporting global drug safety and pharmacovigilance (DSPV) functions for both investigational and marketed productsOversee the DSPV quality management system (QMS) ensuring full GVP and GxP complianceDevelop and implement a risk-based DSPV audit program, and prepare the organization for regulatory inspectionsAct as QA representative to provide compliance guidance across DSPV processes and documentationLead non-compliance investigations, CAPAs, and trending analysesOversee training, inspection readiness, and qualification of DSPV vendors and service providersCollaborate cross-functionally with Drug Safety, QA, IT, and Regulatory Affairs teamsMentor junior QA staff and contribute to long-term team developmentYour Background:10+ years in pharmacovigilance with 5+ years in quality assurance leadershipDirect experience with GVP audits and managing regulatory inspectionsIn-depth understanding of ICH, GVP, GxP, and global regulatory requirementsStrong familiarity with safety database systems and validation (21 CFR Part 11)Demonstrated ability to write and enforce SOPs and manage CAPAsExcellent communication skills and ability to liaise with internal and external stakeholdersWhy Join?This is an opportunity to join a biotech company that’s achieving major clinical and commercial milestones, with a scientifically exciting pipeline and a stable financial foundation. You’ll be joining a purpose-driven organization that offers:A highly competitive benefits package, including full medical coverage for individuals and familiesStrong 401(k) matching and employee equity participationA supportive parental leave program and flexible time-off policyA collaborative and growing team where you can lead and influence key quality systemsIf you are passionate about ensuring the highest standards in drug safety and want to shape QA strategy at a company making real-world impact - this could be your next big step.Reach out to learn more or apply confidentially today.Seniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionScience and ResearchIndustriesPharmaceutical Manufacturing and Biotechnology ResearchReferrals increase your chances of interviewing at Meet Life Sciences by 2xInferred from the description for this job401(k)Vision insuranceMedical insurancePaid maternity leavePaid paternity leaveGet notified about new Director of Quality Assurance jobs in Redwood City, CA.Palo Alto, CA $251,000.00-$292,000.00 3 weeks agoPleasanton, CA $150,000.00-$200,000.00 2 weeks agoSenior Director, Good Manufacturing Practices and Computer System Validation Quality AssuranceSouth San Francisco, CA $225,250.00-$278,250.00 1 month agoFoster City, CA $210,375.00-$272,250.00 1 week agoFoster City, CA $182,070.00-$235,620.00 6 days agoHead of Quality - Design (Director Level)Sr. Director, Global QA Clinical Quality AssuranceFoster City, CA $182,070.00-$235,620.00 3 hours agoSenior Director, Good Clinical Practice and Good Pharmacovigilance Practice Quality AssuranceSouth San Francisco, CA $228,098.00-$281,768.00 1 month agoUnion City, CA $213,282.00-$355,908.00 1 week agoDirector, Clinical Quality Assurance (GCP)Director, Operations & Supplier Quality Assurance - Pleasanton, CAPleasanton, CA $200,000.00-$235,000.00 1 day agoHayward, CA $7,050.00-$9,166.66 9 months agoSan Francisco Bay Area $215,000.00-$255,000.00 3 weeks agoSr Director Clinical Quality Assurance (GCP)South San Francisco, CA $240,000.00-$300,000.00 3 weeks agoHayward, CA $7,050.00-$9,166.66 9 months agoHead of Hardware Product Quality – SpectaclesExecutive Director of Clinical Quality AssuranceSenior Director, GCP/GVP/GLP Quality AssuranceAlameda, CA $209,000.00-$296,500.00 2 weeks agoSouth San Francisco, CA $180,000.00-$225,000.00 1 month agoSenior Director, Clinical Quality AssuranceAssociate Director, Clinical Quality AssuranceRedwood City, CA $185,000.00-$215,000.00 3 weeks agoGlobal Director of Quality, Safety, Health, and Environment (QHSE)Alameda, CA $180,000.00-$240,000.00 6 days agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr