Sr. Manager/Associate Director GCP QA

Senior Manager or Associate Director, GCP QALocation: Redwood City, CA - hybrid, three days onsiteWe are partnering with a profitable, commercial-stage biopharmaceutical company to appoint a Clinical Quality Assurance leader. The level is flexible based on experience. Working alongside the Director and wider QA team, this individual will lead Clinical QA activities across assigned programs while helping shape the function as the company’s clinical pipeline expands.ResponsibilitiesServe as the CQA lead for assigned clinical programs and study teamsProvide GCP compliance oversight throughout the study lifecycleDevelop risk-based audit plans and lead site, TMF, vendor and internal auditsLead inspection-readiness activities and support regulatory inspectionsOversee deviations, CAPAs and critical quality investigationsSupport clinical risk management and critical-to-quality activitiesImprove the CQMS and develop SOPs and GCP trainingMentor junior QA colleagues and, depending on level, oversee assigned team membersQualificationsBA/BS in life sciences or a related field8+ years of relevant clinical research or Clinical QA experienceStrong GCP auditing and clinical quality-systems expertiseRegulatory-inspection and inspection-readiness experienceExperience with CRO oversight, deviations, CAPAs and investigationsAbility to influence cross-functional clinical teamsLeadership or mentoring experience appropriate to the levelThe company offers competitive compensation and benefits.If you are interested, please share your resume with s.viall@kennedybond.com.