QA Operations - Drug Product, QA Manager

What You'll Do

Manage quality oversight at Drug Product Contract Manufacturing Organizations (CMOs). Act as QA operations lead with assigned CMOs, including review of manufacturing batch records and batch release certificates. Ensure CMO SOPs and Master Batch Records are in compliance with cGMPs and serve as technical review for deviations, change records, protocols, and CAPAs generated from or pertaining to Calcilytix or other BridgeBio affiliates, as needed.

Responsibilities

• Represent QA Operations on internal and external project teams, audits and inspections, and participate in monitoring of CMO performance
• Review and manage master and executed manufacturing batch records from CMOs, including release activities, and related documents such as specifications, analytical and microbiological methods, stability study/protocols, process and method validation protocols and reports
• Author and perform quality review of SOPs and quality events (deviations/investigations, OOSs/OOTs, change controls, supplier notifications, etc.)
• Lead Disposition of Drug Product
• Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution
• Support review of regulatory filings
• Support audit of CMOs

Where You'll Work

This role requires in-office collaboration 2-3x per week in our San Francisco office.

Who You Are

• Bachelor's Degree in a science discipline with 8+ years of experience within a biopharmaceutical company, or contract research organization
• Strong knowledge of GMP, SOPs, Quality Systems (e.g. Lot Release, Deviation, Change Control, CAPA,) ICH and GxP principles
• Strong knowledge of FDA and other clinical trial regulations
• Prior experience in QC, Analytical Development and process validation highly desired
• Excellent verbal and written communication skills, with strong customer focus
• Excellent organizational skills, ability to manage multiple tasks and competing priorities, and maintain meticulous attention to detail
• Travel up to 10% total time

Salary

$150,000 - $175,000 USD

Benefits

• Market-leading compensation
• 401(k) with employer match
• Employee Stock Purchase Program (ESPP)
• Pre-tax commuter benefits (transit and parking)
• Referral bonus for hired candidates
• Subsidized lunch and parking on in-office days
• 100% employer-paid medical, dental, and vision premiums for you and your dependents
• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
• Fertility & family-forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility
• Flexible, “take-what-you-need” paid time off and company-paid holidays
• Comprehensive paid medical and parental leave to care for yourself and your family
• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities