Job description: QA Specialist

Company: 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.

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.

• 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

• Bachelor’s degree required; advanced degree preferred
• At least 5-8 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

We Are An Equal Opportunity Employer

Ocyonbio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there is no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

To learn more about us, please visit our website: />