Job Details

Associate Director/Director, Quality Operations and Inspection Management

When 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 Do

The 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.

Responsibilities

• Support GCP and GVP Inspections
• Partner with internal and external stakeholders to support assigned BridgeBio affiliates in inspection-readiness activities
• Support 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 appropriate
• Serve as back-room lead/co-lead for managing requests and inquiries, coordinate responses from relevant personnel during regulatory inspections worldwide
• Support/lead inspection readiness meetings and timelines; coordinate mock inspections and inspection readiness trainings
• Manage inspection commitments and effectiveness checks; maintain Inspection database
• Quality Operations
• Support R&D-related SOP review and approval within QA and across functional areas
• Support development and tracking of QMS and training metrics
• Lead all GCP/GVP QMS activities including system updates, oversight of internal and external deviations, CAPAs, and continuous improvements
• Oversee periodic GCP and GVP training planning and provide guidance on training activities
• Keep abreast of regulatory changes and enforcement actions; recommend policy and practice updates as needed

Location: hybrid role requiring in-office collaboration 2-3 days per week in our San Francisco Office.

Who You Are

• Bachelor's degree with 10+ years of relevant clinical quality experience within a biopharmaceutical company
• Current knowledge of global GxP regulations
• Ability to engage in cross-functional interactions with internal and external staff
• Excellent organizational and verbal/written communication skills with a strong customer focus
• Approximately 10-15% travel

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members and reward those working hard for patients.

• Market-leading compensation
• 401K with 100% employer match on the first 3% and 50% on the next 2%
• Employee stock purchase program
• Referral program with $2,500 award for hired referrals
• Comprehensive health care with 100% premiums covered for employee and dependents
• Mental health support via Spring Health (6 therapy sessions and 6 coaching sessions)
• Hybrid work model
• Unlimited flexible paid time off
• Paid parental leave
• Flexible spending accounts and company-provided group term life and disability
• Subsidized lunch via Forkable on days in office

Skill Development & Career Paths

• Opportunities for growth from discovery to active drug trials and FDA pipelines
• Career pathing through regular feedback, continuous education and professional development programs
• Recognition and growth opportunities for strong performance

Salary: 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.

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