Associate Director CTSM
Shanghai, China | full time | Job ID: 9807
Your main responsibilities are:
- Provide strategic leadership and collaborate with CMC teams to input on Transport Risk Assessments and ensure alignment with organizational goals.
- Develop and oversee efficient and robust supply chain strategies for clinical trials, including network optimization and risk mitigation.
- Lead and manage courier and depot services, including Quality Assurance Agreements (QAA), change management, deviation/complaint handling, and support QA during audits.
- Organize and chair Business Review Meetings, as well as monthly/quarterly supplier performance management reviews, ensuring continuous improvement and alignment with company objectives.
- Drive logistics vendor performance management, including contract negotiations, service level agreements, and performance monitoring.
- Oversee the management of Material Safety Data Sheets (MSDS), dangerous goods transport requirements, and TESS (e.g., freeze-thaw studies).
- Lead Supply Chain Risk Assessments, Transport Verification, and Temperature Monitoring setup, ensuring compliance with regulatory and quality standards.
- Define and implement distribution strategies aligned with CTSM Systems management and IRTSM, including temperature monitoring and excursion handling processes.
- Establish and oversee import/export requirements and country-specific documentation to ensure compliance with global regulations.
- Select and manage vendors for transport, storage, and depot services, ensuring optimal performance and cost-effectiveness.
- Collaborate with global and local study teams to ensure timely delivery of clinical supplies that meet trial needs at sites, including initial and sequential supply.
- Lead demand planning and master planning for local sourcing of drugs by coordinating with study teams and external vendors.
- Provide leadership and mentorship to the supply chain team, fostering professional growth and ensuring alignment with organizational goals.
What you have to offer:
- Relevant completed university education or vocational training in Logistics, Supply Chain Management, or related discipline.
- Minimum of 8 years of professional experience in the pharmaceutical, biotech, or equivalent industry (e.g., trade logistics, CRO logistics, retail logistics), with at least 3 years in a leadership role.
- Proven track record in developing and implementing complex distribution strategies at a global level.
- Demonstrated experience in leading supplier performance management, including contract negotiations and KPI tracking.
- In-depth knowledge of GDP principles, including documentation and operational standards.
- Strong understanding of laws, regulations, ISO requirements, and Incoterms relevant to the pharmaceutical/biotech industry.
- Expertise in controlled temperature shipping, including shipper, container, and route validation requirements.
- Extensive experience with Quality Management Systems and temperature monitoring device calibration requirements.
- Exceptional organizational, analytical, and communication skills.
- Proven ability to lead and mentor teams, manage stakeholders, and collaborate effectively across global and cross-functional teams.
- Ability to solve complex, multi-layered tasks in dynamic and flexible environments.
- Business-professional proficiency in English and Chinese language skills.
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.