Site QA Manager

Job Description

Department: Quality Department

Report To: Site Leader

Industry: Contract Manufacturing (Health Supplement)

Location: Nantong, China

About the Role

Reporting to the Site Leader, the Senior Quality Lead serves as the site’s quality lead, responsible for developing and maintaining a world-class Quality Management System (QMS) that ensures full compliance with GMP (TGA/PIC/S), HACCP, ISO, and FDA regulations. This role independently approves quality documentation, supplier qualifications, and product release, advises on resource planning for the quality function, and plays a critical role in safeguarding product safety while driving operational excellence.

Responsibilities:

🔹 Quality Systems Oversight

• Manage, maintain, and improve the QMS per global GMP, HACCP, FDA, and ISO standards.
• Approve essential documents (e.g., batch records, SOPs, validation plans, Site Master File).
• Lead product release (if applicable), deviation management, change control, CAPA, and recalls.
• Ensure robust investigation processes and preventive actions across site functions.

🔹 Regulatory Compliance & Audits

• Serve as the primary contact for audits and inspections (TGA, FDA, CFDA, EMEA, third parties).
• Lead audit preparation, response drafting, and CAPA follow-through.
• Oversee internal/external audit programs to ensure regulatory and customer alignment.

🔹 Supplier & Outsourced Quality

• Qualify and manage contract manufacturers, CROs, and material suppliers.
• Ensure all third-party activities meet GMP standards and are covered under formal agreements.

🔹 Food Safety & Risk Mitigation

• Lead HACCP plan execution and allergen/control procedures.
• Monitor stability programs, PQRs, and complaints to mitigate quality risks.

🔹 People Leadership & Culture

• Build and develop a high-performing quality team.
• Deliver training on GMP, HACCP, and quality tools to support a proactive compliance culture.

Requirements:

• Education: Degree in Pharmacy, Chemistry, Food Science, or related.
• Experience: 5–8 years in pharma/nutraceutical quality roles; 3+ years in leadership.
• Expertise: GMP (TGA/PIC/S, FDA), HACCP, ISO 9001/22000, and audit preparation.
• Skills: Strong in CAPA, risk analysis, change control, and quality documentation.
• Language: Fluent English required.
• Preferred: TGA GMP, HACCP (GFSI/Codex), ISO 9001/22000 Lead Auditor, Six Sigma/Lean Manufacturing trained, hands-on experience in FDA inspections.

Registration Number: R1331018

Triton AI Pte Ltd

EA License Number: 21C0661