Quality Assurance Lead in Aseptic Manufacturing
4 days ago
We are seeking a seasoned Quality Assurance professional to join our team as an Associate Director/Director of Quality Assurance at our clinical-stage manufacturing facility. This role is ideal for someone with experience in cGMP aseptic manufacturing and quality control within the pharmaceutical or biotech industry.
Key Responsibilities:- Operational QA Support: Provide on-site QA oversight for aseptic drug product manufacturing, including drafting and reviewing batch records, releasing raw materials and finished products, managing deviations, CAPAs, and change controls.
- Metrology Program Support: Develop and review IQ/OQ/PQ documentation for instruments, equipment, and facilities. Oversee scheduling of vendor qualifications and preventive maintenance.
- GxP Training: Design and deliver GxP training programs (GMP, GCP, GLP, CSV), manage training records, and assign curricula.
- Quality Management System (QMS): Develop and review SOPs related to quality assurance, manufacturing, and quality control.
- Auditing & Vendor Management: Conduct internal GxP audits, source data verification, vendor qualification assessments, and risk evaluations.
- Regulatory Compliance: Support regulatory submissions by reviewing technical documents such as technology transfer protocols, process validation reports, and stability studies.
- Metrics & Reporting: Collect and report quality assurance metrics during Quality Management Review meetings.
- Documentation Management: Maintain electronic and paper-based archives of quality documents.
- Bachelor's/Master's degree in engineering or scientific manufacturing disciplines.
- Minimum 5 years' experience in cGMP aseptic manufacturing and quality control within the pharmaceutical or biotech industry.
- Familiarity with global QMS standards (e.g., EU GMP Vol 4, Annexes 1 & 3, 21 CFR 210-212, Part 11, ICH, USP).
- Experience in QA for GCP, GLP, CSV compliance, or radiopharmaceuticals is a plus.
- Strong cross-functional collaboration abilities.
- Commitment to data integrity and adherence to compliance requirements.
- Passion for making an impact in the oncology field for patients in need.
The estimated salary for this position is $120,000 - $180,000 per annum, depending on experience. Additionally, we offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.
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