Senior QA Specialist (Cell Therapy)

General Description:
The incumbent is responsible for set up and maintenance of phase-appropriate quality management systems to support BeOne CGT product manufacturing and ensuring adherence to global regulatory requirements.

Essential Functions of the job:

• Establish and maintain a phase-appropriate quality management system for BeOne CGT products in accordance with BeOne Global Quality Standards and US cGMP, PIC/S GMP, and cGTP requirements.
• Manage controlled documents and records, including the issuance of controlled documents, batch records, and labels, and the archiving of GxP documents and records.
• Manage quality processes, including change control, deviations, CAPA, risk assessments, complaints, and recalls, ensuring timely execution in accordance with SOPs and applicable regulatory requirements.
• Provide QA review and oversight of commissioning and qualification activities for facilities, equipment, and instruments.
• Review batch records, test reports, environmental monitoring records, ongoing stability data, and other relevant documentation to support release or rejection decisions for cell banks and final products.
• Review protocols and reports for analytical method verification and validation.
• Review protocols and reports for aseptic process simulation and process validation.
• Provide quality oversight and coordinate with contract facilities to ensure their services comply with GMP requirements.
• Support internal quality audits against BeOne quality standards and applicable GMP, GTP, and GDP requirements, and support health authority inspection readiness and related activities.
• Conduct GMP- and GTP-related training to support compliance with quality standards and applicable regulatory requirements across business functions.
• Review quality event trends and KPIs to support senior leadership’s quality oversight through Quality Management Review.
• Participate in departmental budget estimation and planning.

Education Required:
Bachelor degree or above, Major in Pharmaceutics, or biotechnology related.

Experience

• At least 3 years of GMP experience in the pharmaceutical or biotechnology industry.
• Experience with parenteral biologics or CGT products is a plus.
• At least 2 years of experience in CGT quality management is highly preferred.
• Demonstrated experience in driving cross-functional projects.
• Ability to adapt quickly to change.
• Experience working on product development projects under tight timelines and uncertain conditions is a plus.
• Fluency in spoken and written English.

Core Competencies, Knowledge and Skill Requirements

• In-depth knowledge of GMP and GTP requirements, FDA and EMA guidance, and USP and EP standards.
• Experience with regulatory inspections.
• In-depth knowledge of quality principles, concepts, industry practices, and standards applicable to aseptically manufactured products.
• Knowledge of quality management for cell and gene therapy (CGT) products.
• Excellent verbal and written communication skills and strong interpersonal skills.
• Ability to analyze and resolve issues calmly under tight timelines and in uncertain situations.
• Ability to work independently and collaborate with departmental and cross-functional teams.

Communication & Interpersonal Skills

• Good interpersonal skills, including listening, writing, negotiations, facilitation of discussions, possesses great attention to detail

Computer Skills:
MS Office skills (Outlook, Word, Excel, PowerPoint)