Senior Quality Assurance Manager

Responsibilities

• Acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier and establishes good working relationships with clear communication and defined actions and goals.
• Negotiation of Quality Assurance Agreements (QAA) with external partners.
• Change and deviation management, complaint handling.
• Escalate risks and issues, as well as propose mitigating actions.
• Responsibility for ensuring timely achievement of project Quality deliverables.
• Contribute to process simplification and QMS improvements.
• Responsible for external supplier qualification and routine monitoring.
• Ensures site readiness for regulatory inspections and quality audits.
• Stability reports and PQR’s review and approval.
• Support Quality activities within transfers, launches and deals.
• Participate quality activities within global projects.

Requirements

• Advanced university degree (Master’s or equivalent) in a relevant field such as Chemistry, Pharmacy, Biotechnology, or Biology.
• Minimum of 10 years’ experience within the pharmaceutical industry, including at least 5 years in the manufacturing of sterile pharmaceutical products.
• Extensive knowledge of aseptic and sterile pharmaceutical processes and strong expertise in the manufacturing of biologics.
• At least 5 years of hands-on experience in operational Quality Assurance within a regulated pharmaceutical environment.
• In-depth understanding of cGMP requirements across major regulated markets, including the EU and US.
• Excellent communicator in both English and Mandarin, with advanced negotiation skills.