Manager, Quality Control

BridgeBio
United States, San Francisco
Workplace: RemoteFull timeUSD 144,000 - 159,700 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 5+ yearsEducation: mastersSkills: ["Communication","Analytical skills","Independent work","Vendor management","Deadline management"]

Ensure analytical activities at partner CMO laboratories are executed in compliance with cGMP, with a major focus on reviewing analytical test packages for release, in-process, and stability testing. Oversee laboratory performance by managing deviations, out-of-spec/out-of-trend results, and vendor follow-ups to close gaps. Coordinate QA review and data loading into the electronic storage program, including method validation/transfer related review, with periodic travel as needed.

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BridgeBio
BridgeBio
1 day ago

Manager, Quality Control

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Source: Company careers pageValidated by: Fursa AI
Last checked: 9 hours agoStatus: Live

Job Summary

Ensure analytical activities at partner CMO laboratories are executed in compliance with cGMP, with a major focus on reviewing analytical test packages for release, in-process, and stability testing. Oversee laboratory performance by managing deviations, out-of-spec/out-of-trend results, and vendor follow-ups to close gaps. Coordinate QA review and data loading into the electronic storage program, including method validation/transfer related review, with periodic travel as needed.
Location: United States, San Francisco
Workplace: Remote
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Review analytical data for release, stability, and in-process testing at contract manufacturing organizations in a timely manner.
  • •Provide oversight of laboratories, including investigations for out-of-specification, out-of-trend, deviations, and/or anomalous results.
  • •Follow up with contract laboratories to correct deficiencies or omissions in provided test packages.
  • •Submit test packages to QA for review and load all data into the electronic storage program.
  • •Review analytical data related to reference standard qualification, method validation, and method transfer activities, with travel as necessary.
Travel: Low travel

Pay and Benefits

Salary: USD 144,000 - 159,700 annually
Equity and Bonus:Equity
Perks:401kEquityHealth InsuranceDentalVisionHsaFsaPaid LeaveParental Leave

Key Requirements

  • •M.S./B.S. in life sciences, ideally Chemistry or Analytical Chemistry.
  • •5+ years of Quality Control experience in a pharmaceutical setting with solid cGMP knowledge.
  • •2+ years management experience.
  • •Ability to effectively communicate with vendors on project scope, scientific results, and updates.
  • •Strong analytical skills and the ability to work independently against multiple deadlines.
Experience:5+ yearsPharmaceuticalQuality controlCGMP
Education:Master's in life sciences; Chemistry; Analytical Chemistry
Skills:CommunicationAnalytical skillsIndependent workVendor managementDeadline management

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn