Manager, Quality Control

About the role

The Quality Control Manager at BridgeBio is responsible for ensuring all activities at CMO laboratories comply with cGMP. Key responsibilities include reviewing analytical test packages for release, in-process, and stability testing, overseeing laboratories, and communicating with vendors.

Responsibilities

• Review of analytical data for release, stability, and in-process testing at CMOs in a timely manner.
• Oversight of laboratories including investigations for out of specification, out of trend, deviations, and/or anomalous results.
• Follow up with CMOs to correct any deficiencies/omissions in the provided test packages.
• Submitting test packages to QA for their review and loading all data into the electronic storage program.
• Review of analytical data related to reference standard qualification, method validation, and method transfer activities.

Requirements

• M.S./B.S. in life sciences, preferably Chemistry or Analytical Chemistry.
• 5+ years’ experience in Quality Control in a pharmaceutical setting with solid knowledge of cGMP.
• 2+ years of management experience.
• Effective communication with vendors regarding project scope, scientific results, and updates.
• Strong analytical skills and ability to work independently against multiple deadlines.

Qualifications

• Experience with regulatory requirements and cGMP guidelines.
• Knowledge of laboratory equipment and techniques.
• Experience with data analysis and interpretation.
• Ability to manage multiple tasks and meet deadlines.

Skills

• Strong analytical skills.
• Excellent communication and interpersonal skills.
• Proficiency in Microsoft Office Suite.
• Ability to work independently and as part of a team.

Benefits

BridgeBio offers a competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. The salary range for this role in California is $144,000 - $159,700 USD. Other benefits include:

• Financial & Rewards: Market-leading compensation, 401(k) with employer match, Employee Stock Purchase Program (ESPP), pre-tax commuter benefits (transit and parking).
• Health & Well-Being: 100% employer-paid medical, dental, and vision premiums for you and your dependents, Health Savings Account (HSA) with annual employer contributions, Flexible Spending Accounts (FSA).
• Skill Development & Career Paths: Regular feedback, continuous education, professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching, career pathing, and growth opportunities.

Pay

$144,000 - $159,700 USD

Schedule

This is a U.S-based remote role with quarterly, or as needed, visits to the San Francisco office.