Role OverviewProvide Quality Assurance oversight for GMP manufacturing operations supporting clinical and commercial Cell & Gene Therapy products. Partner with cross-functional teams to ensure GMP compliance throughout the product lifecycle.
What You Will Do
Identify compliance risks, review and approve validation protocols and reports, support commissioning and qualification activities, and ensure investigations are scientifically sound and compliant with regulatory expectations.
Why It Might Be a Fit
Must have experience providing QA oversight of GMP manufacturing operations, strong knowledge of cGMP regulations, and experience working with electronic quality systems.
Requirements
- Master's degree with 3–5 years of relevant Quality or Validation experience
- Bachelor's degree in Engineering, Life Sciences, Scientific, or related discipline with 8+ years of relevant industry experience
- Experience providing QA oversight of GMP manufacturing operations
- Experience supporting validation programs and capital projects within regulated pharmaceutical, biotechnology, or Cell & Gene Therapy environments
- Strong knowledge of cGMP regulations, quality systems, and validation principles
- Experience supporting aseptic manufacturing operations
- Experience reviewing validation documentation, engineering documentation, and quality system records
- Experience working with electronic quality systems such as Veeva, Nuvolo, ViewLinc, and other enterprise GMP quality applications
Benefits
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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