Are you an experienced professional passionate about quality control? Do you thrive in a fast-paced environment and want to contribute to advancing health solutions? If so, our company invites you to join our Quality Control department as a QC Lab Manager. This role is essential in leading our QC group, ensuring the highest standards of quality and compliance.
Your Core Responsibilities
- Serve as a technical expert in developing, qualifying, and validating bioassay and cell-based potency methods for vaccines, supporting QC release and stability testing within a GMP environment.
- Prepare, review, and approve technical documents, including method protocols, qualification and validation protocols, and reports.
- Provide technical guidance to subordinates and evaluate new analytical technologies to enhance departmental capabilities.
- Support deviations, atypical/OOS investigations, change controls, and CAPAs.
- Lead the team and assist the Potency Lead in achieving departmental goals by streamlining workflows, optimizing processes, and ensuring full compliance.
- Manage regulatory inspections from FDA, EMA, and GMP audits from clients and internal Quality Assurance.
- Act as a point of contact for project coordination, including email and client meetings.
- Enhance QC quality systems and documentation, improve data integrity, and ensure the delivery of high-quality results.
Who You Are
You are ready if you have:
- Bachelor, Master, or PhD Degree in immunology, virology, life science, analytical, or related discipline.
- Proven track record of strong people management, problem-solving, and interpersonal skills.
- Good understanding of analytical and QC operations in the biopharmaceutical/vaccine industry.
- Working knowledge of current regulations and industry trends for vaccine product development, manufacture, and testing, including cGMP, ICH, EMA, FDA, and other global regulations.
Nice to have, but not essential:
- Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.
- Minimum of 8 years of vaccine industry experience preferred, or minimum 10 years relevant pharmaceutical/biopharmaceutical experience in CMC process development and/or GMP manufacturing.
