Quality Assurance Manager – ATP GMP Centre (Ref: CNRM2026-004)

Manufacturing • Full Time • Pak Shek Kok, Hong Kong, HK • 4d ago

Center for Neuromusculoskeletal Restorative Medicine (CNRM) Limited

CNRM based at the Hong Kong Science and Technology Park (HKSTP), combines the talents and expertise in stem cells, biomaterials, 3D bioprinting, tissue engineering, and personalized and translational medicine from The Chinese University of Hong Kong (CUHK).

The Center is a multi-disciplinary, international consortium devoted to the application of convergent principles and technologies of biomedical science and engineering to restore structure and function to neuromusculoskeletal tissues and organs injured, diseased and degenerated due to aging, for the maintenance of mobility and enhancement of quality of life through biomedical research and development.

We are looking for applicants with passion in innovative research, self-motivation, the ability to work independently and in a team, and the capability of working under pressure. The QA Manager leads the Pharmaceutical Quality System (PQS) for the manufacture of Advanced Therapy Products (ATPs) in a PIC/S GMP-compliant facility. This role ensures all operations meet Hong Kong regulatory requirements, international GMP standards, and the unique quality challenges of cell and gene therapies (short shelf-life, patient-specific processes, aseptic handling, and traceability). The position may support the Authorized Person for batch certification and release.

Establish, implement, maintain, and continuously improve the Pharmaceutical Quality System (PQS) in full compliance with PIC/S GMP Guide and local regulations.
Support the Authorized Person: certify that each batch of ATP has been manufactured, tested, and released in accordance with the manufacturing licence, marketing authorisation (or clinical trial requirements), and regulatory standards.
Oversee batch record review, product release, deviation/OOS investigations, CAPA, change control, and complaints/recall procedures.
Plan and execute internal self-inspections, supplier qualification/audits, and preparation for regulatory inspections.
Ensure qualification and validation of facilities (cleanrooms), equipment, processes, analytical methods, and computerized systems, with particular attention to aseptic processing, sterility assurance, and ATP-specific requirements.
Manage documentation control, SOPs, specifications, Product Quality Reviews (PQR), and traceability records (donor-to-recipient) as required for ATPs.
Develop and deliver GMP and ATP-specific training programs for all personnel.
Lead quality risk management and support technology transfer, process validation, and continual improvement initiatives.
Liaise with regulatory authorities, contract partners, and internal stakeholders on quality and compliance matters.

Job requirements:

Bachelor’s degree (or higher) in Pharmacy, Biotechnology, Biomedical Sciences, Biological Sciences, or related discipline. A postgraduate degree or PhD is highly preferred for ATP manufacturing.
6–10+ years of progressive QA experience in pharmaceutical or biopharmaceutical GMP manufacturing, with at least 3 years in a managerial role. Direct experience in ATPs is strongly preferred.
In-depth knowledge of PIC/S GMP and ICH guidelines, plus Hong Kong ATP regulations.
Experience preparing for and hosting regulatory inspections (DoH/PPB or equivalent).
Strong leadership, problem-solving, and communication skills (English and Chinese; Cantonese/Mandarin an advantage).
Authorized Person eligible is a plus.

The appointment will initially be made on a contract basis commencing as soon as possible, renewable subject to good performance and mutual agreement.

The information provided will be kept confidential and only be used for those purposes relating to your application. We are an equal opportunities employer and welcomes applications from all qualified candidates.

Job Type: Full-time

Work Location: In person

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