Associate Director, QA CDMO Oversight (Shanghai, SH, CN, 200050)

中国，上海   |   全职   |   Job ID: 11736

About the role:

Associate Director, QA CDMO Oversight is responsible for overseeing the quality assurance activities at CDMO sites within a global biopharmaceutical company, BioNTech, in China. The incumbent will ensure compliance with regulatory requirements, industry standards, BioNTech internal policies, standards, and SOPs for the manufacturing and testing, release, storage, and distribution of biological products (clinical and commercial). The incumbent will provide quality oversight of contract organizations, drive continuous improvement initiatives, work with cross-functional teams, and ensure the highest standards of product quality and patient safety.

Your contribution:

Ensure that CDMOs comply with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards through PIP, audits and monitoring.

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

Lead and manage GMP audits at contract manufacturers and laboratories.

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

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

Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events occurred CDMO sites.

Support the development and review of master batch records, specifications, test methods, protocols and other critical documents.

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

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

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.

BioNTech 重视每一位团队成员的福祉，为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案，具体将根据职位、工作地点及候选人资历与经验综合确定。注：各项福利的实际适用范围、享有条件及具体内容可能因所在地而异，最终以公司内部政策及当地法律法规为准。

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重要提示：

我们仅接受通过链接在线提交的求职申请。

提交申请即视为您知悉，招聘流程中将依相关法律法规进行背景调查。如您进入候选名单，BioNTech 将通过合作服务机构“HireRight”开展背景调查工作，招聘专员将及时与您沟通具体安排。

我们诚挚期待您的加入。

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