Senior Manager in Quality Engineering at PwC leading quality engineering efforts and mentoring teams. Responsible for maintaining software quality standards and innovating operational processes.
About the role
- Manager of QA Compliance overseeing Quality Agreements in biotech firm BridgeBio Pharma. Collaborating cross-functionally for compliance and inspection readiness in FDA-regulated environments.
Responsibilities
- Lead and manage global Quality Agreements/QTAs by developing, reviewing, executing, and maintaining agreements, ensuring compliance with the scope of services, regulatory requirements, internal standards, and all terms and conditions
- Collaborate with internal cross-functional teams and external stakeholders (e.g., contract service providers) to bring Quality Agreements to an approvable state
- Track Quality Agreement renewal and revision cycles
- Support regulatory authority inspection readiness activities at CSP and internally
- Participate in the global supply chain vendor qualification process to ensure compliance with regulatory and internal standards
- Participate in the planning of internal audits
- Ensure audit findings are followed up on, corrective actions are completed, implemented, and verified to ensure compliance
- Identify and assess risks to compliance, develop mitigation strategies, and ensure effective implementation
- Maintain master vendor list with up-to-date Health Authority certification/licenses
- Maintain risk registers and communicate risk trends to Quality leadership
- Develop, track, analyze, and present Quality Compliance metrics, including audit data, CAPA performance, Quality Agreement KPIs, risk assessments, and vendor performance indicators
- Prepare quality dashboards and monthly/quarterly reports for management review
- Support SOP development and revision related to Quality Agreements, auditing, risk management, and metrics
- Other duties as assigned
Requirements
- Bachelor's degree in a scientific discipline; an advanced degree is a plus
- A minimum of 8+ years of experience working in a Biotech or Pharmaceutical FDA-regulated industry in QA or a related field, or an equivalent combination of education, training, and/or experience from which comparable knowledge, skills, and abilities have been attained
- Hands-on experience drafting commercial Quality Agreements with various scopes of services
- Prior experience in vendor qualification processes
- Excellent communication, relationship-building, and technical writing skills
- Strong knowledge of global GxP regulations (FDA, EMA, ICH)
- Prior experience in leading/supporting PAI readiness activities
- Ability to work in a virtual environment
- Ability to thrive in a dynamic, fast‑paced, cross‑functional environment
- Willingness to travel both domestically and internationally as required
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered - no cost to you and dependents
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- Hybrid work model - employees have the autonomy in where and how they do their work
- Unlimited flexible paid time off - take the time that you need
- Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
- Flex spending accounts & company-provided group term life & disability
- Subsidized lunch via Forkable on days worked from our office
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