Associate Director, Quality Assurance, Change Controls

Associate Director, QA Change Control, Pharmaceuticals, ConsultantSummaryOur client, a biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with significant unmet needs, particularly in eye care, has engaged with GForce to identify a Quality Assurance consultant. This person will be responsible for the review and processing of manufacturing Deviations and laboratory OOS and review of manufacturing and laboratory-related Change Controls within the established QMS system. This role will also be responsible for the approval of Certificates of Analysis, manufacturing batch record review, and product disposition.Duties / Expectations of RoleSupport QA activities for early-phase (preclinical through clinical phase I/II) clinical development programsEnsure compliance with GMP in addition to internal policies and proceduresProvide strategic QA input to cross functional teams, including Clinical, Regulatory Affairs, Analytical Development and CMCServe as QA representative on development project teams and advise on risk mitigation strategiesContribute to the authoring and review of SOPs, protocols, reports and specificationsProcess and approve change controls, OOS and deviations within the QMS systemReview and approve CMO's master batch records, analytical documents and validation protocolsReview executed batch records and disposition batches per internal policies and proceduresParticipate in CMO and internal operations meetingsMandatory RequirementsBachelor's or advanced degree in life science or a related fieldSterile injectable products experience10 years of experience in Quality Assurance within the pharmaceutical / Biotechnology industryExperience in early-phase clinical development and a sound understanding of the drug development life cycleStrong knowledge of deviation and change control systems.Laboratory background with method methodsExperience with investigations using root cause analysis, CAPA and CAPA effectivenessASQ Certification PreferredTerm & Start6-month contract with intent to convert to FTEHybrid 2-3 days a week in Irvine, CA

Created: 2025-06-05