Manager, QA Operations

BridgeBio Pharma

9h•Hybrid

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

Bachelor’s degree in a scientific discipline with 6+ years of experience within a biopharmaceutical company and at least 4+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment.
Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing and packaging operations (including serialization) in the United States and globally in support of global commercial production activities.
Strong communication and collaboration skills with the ability to influence stakeholders in a matrix environment.
Ability to exercise good judgment and make decisions that align with organizational objectives.
Results-driven mindset, taking initiative and ownership of assigned tasks.
Demonstrated flexibility and adaptability in a dynamic, rapidly growing environment.
Commitment to continuous improvement and embracing innovative approaches in daily work.

Nice To Haves

Experience with Veeva platform highly preferred.

Responsibilities

Serve as the quality lead for commercial packaging operations at assigned CSPs, providing oversight across primary/secondary packaging, labeling, and serialization to ensure GMP and GDP compliance.
Review executed batch records and compile batch documentation packages to support lot disposition and market release.
Provide quality review of deviations, change controls, CAPAs, and risk assessments related to packaging operations.
Review and provide quality input on tech transfer, process validation, and shipping qualification protocols and reports through preparation, execution, and closure.
Communicate/escalate manufacturing deficiencies/non-conformances to management, present issues during escalation, and work with CMOs to ensure timely resolution
Support review of CMC sections and regulatory filings.
Author, review, and maintain QA Operations SOPs and controlled documents.

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)
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
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities