Job Description:
Client: Biotechnology Company
Project Details:
- 6-Month contract
- 40 hours per week.
- Bi-weekly on-site requirement
Key Responsibilities:
- Provide quality oversight of outsourced GMP operations (CMC, CDMO, contract labs).
- Review and approve/reject policies, batch records, test methods, and change controls.
- Perform lot disposition of drug substances, products, and clinical materials.
- Support investigations, deviations, and CAPAs to ensure compliance.
- Assist with regulatory audits and vendor qualifications.
- Present quality metrics and drive continuous improvement initiatives.
Requirements:
- Bachelor's degree in molecular biology, biochemistry, or related field (Master's preferred).
- 10+ years of QA management experience in biotechnology or medical devices.
- Strong knowledge of cGMPs, FDA, and international regulations.
- Excellent communication, organization, and mentoring skills.