Director, Quality Assurance (Pharma)

Director, Quality Assurance, PharmaLocation: Redwood City, CA (hybrid model)Type of role: FTE, Full time Salary: plus bonus and equityJob DescriptionDevelop and implement GXP including GMP quality systems in accordance with ICH, FDA, EMA and global competent authority regulations and industry guidanceReview all GXP documents/reports especially as they relate to method development, validation activities and PPQ generation resultsProvide compliance oversight for internal and contracted external GXP activitiesCoordinate and implement audit plans and audit reports for all CROs, CDMOs, and GMP vendors and internal departments.Coordinate and perform virtual or on-site audits as neededProvide quality oversight for GMP CDMOs (including quality agreements) and manage GMP product batch record review and disposition.Lead and ensure inspection readiness activities for all internal and external entitiesHost GMP inspections. Follow up to any responses and CAPAsDevelop, implement, and manage the quality management systems including vendor management, change control, product label review, risk management, GXP computer systems, deviation and CAPA systemsDevelop and implement overall GXP strategy, performance metrics, analytics, and reportsEnsure and record periodic SOP trainings for all employees including onboarding FTEs and contractors in the GXP system as applicableQualificationsBachelor's degree in biological sciences or related field with minimum of 10 years' experience in a pharmaceutical setting.Proven, extensive knowledge of worldwide GXP regulatory requirements, industry practices, and ability to apply concepts. Experience with GMP regulations and current industry standards.Experience in designing and implementing quality systems and risk management toolsExperience interacting with and managing CMOs for DS and DP especially biological productsExperience leading/hosting US and international health authority inspections/interactionsExcellent interpersonal, verbal, and written communication skills are critical in our collaborative work environmentMust demonstrate high organizational, prioritization and management proficienciesAbility to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities