Shanghai Associate Director, Global Development Quality Assurance SH 200050

Job description

Shanghai, China | full time | Job ID: 11919 About the role: As Associate Director, Clinical Quality Assurance Compliance, you will help ensure clinical development activities meet quality standards and regulatory requirements. Your work supports BioNTech’s mission by helping protect patient safety, rights and well-being throughout clinical research. You’ll partner with clinical trial teams and colleagues across a global, cross-functional environment. By applying proactive, risk-based quality oversight, you’ll help trials stay inspection-ready and support continuous improvement across clinical development. Your contribution: • Shape and implement proactive, risk-based quality strategies for assigned clinical trials, applying Good Clinical Practice and Quality by Design principles • Advise trial teams on quality risks, deviations and investigations, and guide robust corrective and preventive actions through to effectiveness checks • Provide quality input to trial decisions and documentation, and maintain clear dashboards that track risks, findings, actions and key milestones • Coordinate inspection readiness, including preparation of narratives, sites, records and mock inspections, and support health authority inspections and follow-up • Oversee audit planning and follow-up, and work with external partners to support quality agreements and compliance • Contribute to quality initiatives, procedures and a culture of transparency, speak-up and continuous improvement across clinical development A good match: • Bachelor’s degree in medicine or another life science; an advanced degree is preferred • Experience in Good Clinical Practice, clinical development quality assurance or quality management, including regulatory inspections, quality systems or training • Knowledge of drug development regulations and guidance, including requirements from NMPA, FDA, EMA and ICH • Experience supporting escalations and corrective and preventive actions, and working with external partners such as contract research organizations • Fluent English, with strong written and verbal communication skills; confident with Microsoft Office and electronic quality management systems • Collaborative and clear in a global, cross-functional environment, with the judgment to address quality concerns proactively Your benefits: BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law. How to apply: Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form. Please note: Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter. We are looking forward receiving your application. Inspired? Become part of #TeamBioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company – we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine. Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world. BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you! BioNTech - As unique as you www.biontech.com Apply now » Find similar jobs: Alle Stellen, All Jobs • Terms of Use • General Terms and Conditions • Data Privacy Statement • Imprint • Cookie Settings © 2024 BioNTech SE. 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