- Lead and grow the site Quality Assurance group
- Ensure compliance with cGMP regulations
- Manage quality aspects of customer projects
- Oversee compliance audits
- Review batch records, manage deviations, and quality events
- Lead Quality Management Review
- Support new product introduction and validation activities
- Manage departmental goals and budget
- Recruit and build a high-performance team
- Bachelor's degree in Life Sciences or related field
- 10+ years of experience in pharmaceutical or biopharmaceutical industries
- Leadership experience and knowledge of cGMP regulations
- Experience with Cell and Gene Therapy products preferred
- Strong communication and people management skills
- Self-motivated with a passion for advancing cell therapies
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Director, Quality Assurance - South San Francisco, United States - Cellares
Description
We are looking for a highly motivated Director of Quality Assurance to join our team in South San Francisco. This role involves developing, implementing, and maintaining a quality management system for our Cell & Gene Therapy operations, supporting pre-clinical and clinical manufacturing.
About the Role:
Requirements:
About the Company:
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) focused on mass manufacturing living drugs. Our Cell Shuttle technology enables end-to-end automation for cell therapy manufacturing, meeting global patient demand. Partnering with us accelerates drug development, lowers costs, and ensures scalability.
Headquartered in South San Francisco, California, with a Smart Factory in Bridgewater, New Jersey, Cellares is backed by top investors with over $355 million in financing.
Total Compensation:
$170,000 - $220,000 annually, competitive base salaries, subsidized benefits, 401(k) Matching, EV Charging, Onsite lunches, and Stock options.
All pay ranges are approximate, negotiable, and location-dependent. Leveling will be determined based on experience and knowledge demonstrated during the interview process.
