Join our company as a QC Lead and play a crucial role in ensuring the highest quality standards in our products and services. This is an exciting opportunity to lead a dynamic team, drive continuous improvement, and make a significant impact on our quality programs.
Your Core Responsibilities
- Develop and lead a world-class cell-based potency assay QC team, including planning, recruiting, coaching, and training. This role will enable you to shape and enhance our team’s capabilities.
- Serve as a technical expert to develop, qualify, and validate bioassay/cell-based potency methods for vaccines in a GMP environment.
- Prepare, review, and approve technical documents such as method protocols and validation reports.
- Provide technical guidance, evaluate new analytical technologies, and enhance department capabilities.
- Oversee GMP quality oversight, including deviations, investigations, change controls, and CAPAs.
- Manage lab scheduling and planning for Vaccines QC labs, ensuring streamlined workflows and operational efficiency.
- Lead project management interactions with internal and external clients, including Quality Assurance and Regulatory Affairs.
- Handle regulatory inspections and GMP audits, ensuring continuous improvement of QC quality systems and safety measures.
Who You Are
You are ready if you have:
- Ph.D. or MSc in Microbiology related to immunology or Virology.
- Strong understanding of analytical and QC operations in the biopharmaceutical/vaccine industry.
- Proven track record in people management, problem-solving, and interpersonal skills.
- Knowledge of current regulations and industry trends for vaccine development, manufacture, and testing, including cGMP, ICH, EMA, and FDA guidelines.
- Proven ability to lead continuous improvement initiatives to enhance quality standards and operational efficiency within the QA potency team.
- Exceptional skills in collaborating with cross-functional teams to integrate QA potency processes and address issues promptly.
- Strong leadership skills, including strategic planning, innovation, and talent development, with a commitment to diversity, equity, and inclusion.
Nice to have, but not essential:
- 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.
- Experience with vaccines/viral testing and biosafety containment levels, preferably BSL-3.
- Proven track record working cross-functionally across a wide variety of technical, business, and operational areas.
