Manager, QA Operations
About The Position
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.
Requirements
- Bachelors degree in a scientific discipline
- 5+ years of relevant Quality experience (QA or QC) within a biopharmaceutical company, or contract research organization
- Prior experience reviewing packaging master and executed batch records
- Good organizational skills, ability to manage multiple tasks and maintain meticulous attention to detail
- Strong knowledge of global GxP regulations (FDA, EMA, ICH)
- This position requires travel - 10% total time will be used for travel
Responsibilities
- Manage quality assurance lot release activities at the company's contract manufacturing organizations(CMOs).
- Act as a quality liaison with assigned CMOs, including review of packaging batch records and the issuance of certificates of compliance.
- Ensure that the CMO SOPs and batch records are in compliance with cGMPs.
- Serve as the technical quality reviewer for deviations, change records, protocols, and CAPAs generated from or pertaining to packaging CMOs.
- Review and manage master and executed packaging batch records from CMOs.
- Review process validation protocols and reports.
- Perform quality review of quality events (deviations, product complaints, investigations, change requests, supplier notifications, etc.).
- Manage lot release activities.
- Communicate packaging deficiencies/non-conformances to management and work with CMOs to ensure timely resolution.
- Represent QA on project teams and participate in monitoring of CMO performance.
- Participate as Person-In-Plant, internal and external project team meetings, vendor audit, partner audit and regulatory inspections, as needed.
- Write and review SOPs and quality assurance procedures, as needed.
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
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
251-500 employees
