Associate Director, QA Compliance & Release (Shanghai, SH, CN, 200050)

中国，上海   |   全职   |   Job ID: 11738

About the role:

Associate Director, QA Compliance & Release is responsible for the sponsor QA release of the drug products manufactured by CDMOs or BioNTech subsidiaries and used in the clinical trials sponsored by BioNTech China. The incumbent will ensure quality compliance with China regulatory requirements, industry standards, and BioNTech internal policies, standards, and SOPs for the manufacturing, testing, release and distribution of biological products (clinical and commercial). The incumbent will assist in the establishment of the sponsor product release and quality compliance related SOPs and systems. The incumbent will drive continuous improvement initiatives, work with cross-functional teams, and ensure the highest standards of product quality and patient safety.

Your contribution:

Establish sponsor specific product release and oversight of the CDMO according to the China regulations.

Review and approve master batch records, specifications, test methods, protocols and other critical documents.

Represent as a sponsor QA to release products for clinical trials in Asia Pacific.

Review quality activities (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review) at the CDMO sites.

Provide expert guidance on GMP compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management.

Support regulatory inspections at CDMO sites, ensuring inspection readiness and timely resolution of findings at CDMO sites.

Participate in GMP audits at contract manufacturers and laboratories.

Participate in GMP QA in regulatory inspections, partner audits, and due diligence activities.

Participate in identification, assessment, and mitigation of GMP-related risks across the supply chain (end to end).

Foster a culture of quality, accountability, and collaboration within the team and across the organization and with CMDOs.

Partner with manufacturing, analytical development and quality control, supply chain, regulatory affairs, and R&D to ensure alignment on quality and compliance objectives.

Participate in the selection, qualification and ongoing monitoring of all CDMOs, including contract manufacturers and testing laboratories.

Ensure CDMOs’ compliance with contractual obligations, quality agreements and regulatory requirements.

A good match:

Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field is a must, Advanced degree in life sciences, pharmacy, chemistry, or a related field (MS, or above) is preferred.

Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, with at least 5 years in GMP QA or manufacturing quality roles working in a firm with in-house manufacturing.

Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Strong knowledge of global GMP regulations, ICH guidelines, and monoclonal antibody manufacturing processes.

Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities.

Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.

Strategic thinker with a focus on continuous improvement and innovation.

This role may require travel (up to 30%) for audits, PIPs, and meetings.

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