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Manager, QA Compliance

10 hours, 56 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

  • Lead and manage global Quality Agreements/QTAs through development, review, execution, and maintenance.
  • Collaborate with internal cross-functional teams and external contract service providers to move Quality Agreements to an approvable state.
  • Track Quality Agreement renewal and revision cycles.
  • Support regulatory authority inspection readiness activities at contract service providers and internally.
  • Participate in global supply chain vendor qualification processes to ensure compliance with regulatory and internal standards.
  • Help plan internal audits and follow up on findings, corrective actions, and verification activities.
  • Identify compliance risks, develop mitigation strategies, and support implementation.
  • Maintain the master vendor list, including current Health Authority certifications and licenses.
  • Maintain risk registers and communicate risk trends to Quality leadership.
  • Develop, track, analyze, and present quality compliance metrics, dashboards, and monthly/quarterly management reports.
  • Support SOP development and revisions related to Quality Agreements, auditing, risk management, and metrics.

Requirements

  • Bachelor's degree in a scientific discipline; an advanced degree is a plus.
  • 8+ years of experience in a biotech or pharmaceutical FDA-regulated industry in QA or a related field.
  • Equivalent combinations of education, training, and experience may be considered.
  • Hands-on experience drafting commercial Quality Agreements with various scopes of services.
  • Prior experience in vendor qualification processes.
  • Strong knowledge of global GxP regulations, including FDA, EMA, and ICH.
  • Prior experience leading or supporting PAI readiness activities.
  • Excellent communication, relationship-building, and technical writing skills.
  • Ability to work effectively in a virtual environment and thrive in a dynamic, fast-paced, cross-functional setting.
  • Willingness to travel domestically and internationally as required.

Benefits

  • Salary range of $126,400 to $152,700 USD for California-based candidates.
  • Market-leading compensation with an 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 with annual employer contributions, plus Flexible Spending Accounts.
  • Flexible, remote-friendly hybrid work model with quarterly or as-needed visits to the San Francisco office.
  • Flexible, take-what-you-need paid time off and company-paid holidays.
  • Comprehensive paid medical and parental leave.
  • Expanded mental health support, including therapy and coaching resources.
  • Pre-tax commuter benefits and subsidized lunch and parking on in-office days.
  • Career development resources, including LinkedIn Learning, LifeLabs, and BetterUp Coaching.

Interested in this position?

Apply directly on the company website

Apply Now

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