Associate Director/Director, Quality Operations and ...

Associate Director/Director, Quality Operations and Inspection ManagementWhen was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement, read on.Calcilytix Therapeutics, an affiliate within BridgeBio Pharma, is developing encaleret, a negative allosteric modulator of the calcium-sensing receptor (CaSR) for the treatment of Autosomal Dominant Hypocalcemia Type 1 (ADH1). Encaleret is currently being evaluated in a Phase 3 clinical study and has received Orphan Drug Designation from the US FDA, EMA, and PMDA as well as Fast Track Designation from the US FDA. Results from the Phase 2b clinical study of encaleret in patients with ADH1 were published in the New England Journal of Medicine.What You’ll DoThe Associate Director/Director, Quality Operations and Inspection Management is responsible for supporting GCP and GVP inspections and assisting the organization with developing and continuously improving processes and systems. This role requires strong organizational skills to manage inspection readiness and SOP activities and timelines. Strong knowledge of GCP and GVP related regulations is preferred.ResponsibilitiesSupport GCP and GVP InspectionsPartner with internal and external stakeholders to support assigned BridgeBio affiliates in inspection-readiness activitiesSupport cross-functional teams during preparation, execution, and closure of GCP and GVP health authority inspections; coordinate with vendors and investigational sites for external inspections as appropriateServe as back-room lead/co-lead for managing requests and inquiries, coordinate responses from relevant personnel during regulatory inspections worldwideSupport/lead inspection readiness meetings and timelines; coordinate mock inspections and inspection readiness trainingsManage inspection commitments and effectiveness checks; maintain Inspection databaseQuality OperationsSupport R&D-related SOP review and approval within QA and across functional areasSupport development and tracking of QMS and training metricsLead all GCP/GVP QMS activities including system updates, oversight of internal and external deviations, CAPAs, and continuous improvementsOversee periodic GCP and GVP training planning and provide guidance on training activitiesKeep abreast of regulatory changes and enforcement actions; recommend policy and practice updates as neededLocation: hybrid role requiring in-office collaboration 2-3 days per week in our San Francisco Office.Who You AreBachelor’s degree with 10+ years of relevant clinical quality experience within a biopharmaceutical companyCurrent knowledge of global GxP regulationsAbility to engage in cross-functional interactions with internal and external staffExcellent organizational and verbal/written communication skills with a strong customer focusApproximately 10-15% travelRewarding Those Who Make the Mission PossibleWe have high expectations for our team members and reward those working hard for patients.Market-leading compensation401K with 100% employer match on the first 3% and 50% on the next 2%Employee stock purchase programReferral program with $2,500 award for hired referralsComprehensive health care with 100% premiums covered for employee and dependentsMental health support via Spring Health (6 therapy sessions and 6 coaching sessions)Hybrid work modelUnlimited flexible paid time offPaid parental leaveFlexible spending accounts and company-provided group term life and disabilitySubsidized lunch via Forkable on days in officeSkill Development & Career PathsOpportunities for growth from discovery to active drug trials and FDA pipelinesCareer pathing through regular feedback, continuous education and professional development programsRecognition and growth opportunities for strong performanceSalary: The anticipated salary range for this role in California is $170,000 - $235,000 USD. Final salary depends on factors including experience, education, location, and interview performance.Apply for this jobInterested in building your career at BridgeBio Pharma? Get future opportunities sent straight to your email. #J-18808-Ljbffr

Created: 2025-09-17