Senior QA Specialist
About The Position
OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies. OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements. PLACE OF PERFORMANCE: CII GEORGE SANDERS, AGUADILLA PUEBLO, AGUADILLA P.R. 00603. ROLE SUMMARY Provides strategic and technical leadership for the Pharmaceutical Quality System, ensuring robust quality oversight of facility start-up, technology transfer, analytical method transfer, manufacturing process transfer, and sustained commercial GMP operations.
Requirements
- Bachelor’s degree required; advanced degree preferred
- At least 8 years of QA experience in sterile biologics manufacturing
- Demonstrated leadership in quality systems and regulatory interactions
- Strong quality mindset aligned with ICH Q10 Pharmaceutical Quality System principles
- Risk-based decision making (ICH Q9) and lifecycle approach to quality
- Excellent GMP documentation and data integrity practices
- Cross-functional collaboration in start-up and technology transfer environments
- Continuous improvement and inspection readiness focus
Responsibilities
- Provide strategic QA leadership aligned with ICH Q10 principles
- Lead high-impact quality risk assessments and CAPA programs
- Oversee quality aspects of technology transfer and process lifecycle management
- Support regulatory inspections, submissions, and client audits
- Mentor QA staff and drive continuous improvement initiatives
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
