San Francisco, Irvine, WorcesterFull TimeEngineering
Remotely
quality assurancedue diligencecmcregulatorygmpanalytical testing
Job Description
📋 Description
- Provide QA oversight for clinical development programs and quality strategy
- Lead risk management and executive-level program status communication
- Represent QA on CMC and cross-functional product teams
- Define risk-based quality positions across manufacturing and supply
- Oversee integration with partners, licensing, and third-party groups
- Drive global process improvements for quality, compliance, and inspection readiness
🎯 Requirements
- Bachelor’s in life sciences, chemistry, biology, engineering or related field
- 8+ years in QA, production, testing of APIs or related field
- Experience in pharmaceutical development and clinical product supply
- Knowledge of GMP, regulatory expectations (US/EU)
- Experience with due diligence, partnerships, tech transfers, or post-transaction integration
- Strong leadership, communication, and cross-functional influence
🎁 Benefits
- Competitive compensation package
- Benefits including PTO, medical/dental/vision, 401(k)
- Eligibility for long-term incentive programs
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