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Sr. Manager, QA Operations - Product Release

11 hours, 55 minutes ago
United States
Full-time
Lead
Manual QA Tester
Quality Assurance and Testing
Apply Now
bridgebiowp

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals
251-1K
Founded 2014
$2300M raised
View All Jobs 18

Description

  • Manage lot release activities at contract manufacturing organizations (CMOs).
  • Serve as QA Operations lead for assigned CMOs and oversee quality release decisions.
  • Review manufacturing batch records, certificates of analysis, and issue certificates of compliance.
  • Ensure CMO SOPs and master batch records comply with cGMP requirements.
  • Act as the technical quality reviewer for deviations, change records, protocols, and CAPAs related to Calcilytix or other BridgeBio affiliates.
  • Represent QA Operations on internal and external project teams, audits, and inspections.
  • Monitor CMO performance and support audit activities for CMOs.
  • Review and manage master and executed manufacturing batch records and related release documentation, including specifications, analytical and microbiological methods, stability protocols, and validation reports.
  • Author and perform quality review of SOPs and quality events, including deviations, investigations, OOSs/OOTs, change controls, and supplier notifications.
  • Lead disposition of drug substance, drug product, and finished product.
  • Communicate and escalate manufacturing deficiencies and non-conformances, and work with CMOs to resolve issues in a timely manner.
  • Support review of regulatory filings.

Requirements

  • Bachelor's degree in a science discipline.
  • 8+ years of experience within a biopharmaceutical company or contract research organization.
  • Strong knowledge of GMP, SOPs, and quality systems such as lot release, deviation, change control, and CAPA.
  • Knowledge of ICH and GxP principles.
  • General knowledge of FDA and other global clinical trial regulations.
  • Prior experience in QC, analytical development, and process validation is highly desired.
  • Excellent verbal and written communication skills with a strong customer focus.
  • Excellent organizational skills with the ability to manage multiple tasks, competing priorities, and meticulous attention to detail.
  • Ability to travel up to 10% of total time.
  • Demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.
  • Hybrid work arrangement with in-office collaboration 2-3 times per week in San Francisco, or U.S.-based remote with quarterly or as-needed visits to San Francisco.

Benefits

  • Market-leading compensation with a California salary range of $160,200 to $185,500 USD.
  • Annual performance bonus and company equity.
  • 401(k) with 100% employer match on the first 3% and 50% on the next 2%.
  • Employee stock purchase program.
  • Comprehensive health coverage with 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • Health Savings Account with annual employer contributions plus Flexible Spending Accounts.
  • Mental health support through Spring Health, including therapy and coaching sessions.
  • Flexible hybrid work model and unlimited flexible paid time off, plus company-paid holidays.
  • Paid parental leave, including 4 months for birthing parents and 2 months for non-birthing parents.
  • Pre-tax commuter benefits, subsidized lunch on office days, and referral bonuses for hired candidates.
  • Career development support through LinkedIn Learning, LifeLabs, BetterUp Coaching, and internal mobility opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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