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Manager, QA Operations

3 weeks, 3 days ago
United States
Full-time
Senior
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 36

Description

  • Serve as the quality lead for commercial packaging operations at assigned contract service providers.
  • Provide oversight of primary and 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 tech transfer, process validation, and shipping qualification protocols and reports through preparation, execution, and closure.
  • Communicate and escalate manufacturing deficiencies and non-conformances, and work with CMOs to drive timely resolution.
  • Support review of CMC sections and regulatory filings.
  • Author, review, and maintain QA Operations SOPs and controlled documents.

Requirements

  • Bachelor’s degree in a scientific discipline.
  • 6+ years of experience within a biopharmaceutical company.
  • 4+ years of experience in Quality Operations roles in a cGMP environment.
  • Strong working knowledge of FDA regulations, including 21 CFR 210/211.
  • Knowledge of ICH guidelines and global regulations, including EU Directives and ROW requirements.
  • Expertise in cGMP requirements for manufacturing and packaging operations, including serialization, in the U.S. and globally.
  • Experience with the Veeva platform is highly preferred.
  • Strong communication and collaboration skills with the ability to influence stakeholders in a matrix environment.
  • Ability to exercise good judgment and make decisions aligned with organizational objectives.
  • Up to 15% domestic and international travel required.

Benefits

  • Market-leading compensation with a salary range of $135,700 to $175,000 USD.
  • Annual performance bonus.
  • Company equity and Employee Stock Purchase Program (ESPP).
  • 401(k) with employer match.
  • 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • Health Savings Account (HSA) with annual employer contributions plus Flexible Spending Accounts (FSA).
  • Flexible, hybrid work model with in-office collaboration 2-3 times per week or quarterly/as-needed office visits for remote employees.
  • Flexible take-what-you-need paid time off, company-paid holidays, paid medical leave, and parental leave.
  • Subsidized lunch and parking on in-office days.
  • Expanded mental health support, including therapy and coaching resources.
  • Fertility and family-forming benefits.
  • Career development support through regular feedback, LinkedIn Learning, LifeLabs, and BetterUp coaching.

Interested in this position?

Apply directly on the company website

Apply Now

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