Associate Director CTSM, Supply Integration & Integrity
BioNTech · Mainz
Mainz, Germany | full time | Job ID: 11841
About The Role:
As Associate Director CTSM Supply Integration & Integrity, you will act as a CTSM-wide enabling and governance role responsible for ensuring sustainable audit and inspection readiness, quality compliance, and continuous improvement across Clinical Trial Supply Management. The role serves as the central CTSM contact for QA-related topics, coordinates audit and inspection preparation activities, drives issue and findings management, oversees CAPA execution, governs CTSM TMF strategy and filing practices, and provides guidance, harmonization, and lessons learned across the function.
Your Contribution:
- Enable CTSM to be audit and inspection ready
- Act as CTSM Single Point of Contact (SPOC) and Inspection Support Team (IST) representative for Audits and Inspections e.g. by coordinating in CTSM consolidated preparation and responses to requests prior handover to QA for quality check
- Act as CTSM Audit and Inspection Finding Owner
- Oversee and enable CTSM addressing clinical trial supply management findings including implementing corrective and preventive actions (CAPAs)
- Owns the CTSM issue management, root cause analysis and efficient lessons learned processes
- Oversee CTSM TMF index, own CTSM filing strategy in alignment with Global Development Excellence and conduct TMF index updates in CTSM
- Enable CTSM in filing required documentation (e.g. in the Trial Master File and repositories owned by CTSM)
- Lead and oversee CTSM Sponsor Oversight strategy
- Enable IMPMs and other CTSM functions to deliver records in time (e.g. Deviations, Change Controls)
- Support harmonization and simplification on the above-described activities; ensure efforts are in alignment with gaining efficiency and remaining required flexibility
- Act as CTSM QAA Spoc
A Good Match:
- Completed university degree in Engineering, Supply Chain Management, Quality Management, or related discipline (Doctorate preferred)
- Minimum 5 years of experience in Clinical Trial Supply Management, Quality Management within Pharmaceutical or Biotech or regulated industries
- Advanced experience in dealing with agencies/authorities e.g., FDA, EMA, BSI, etc.
- Proven Audit and/or Inspection relevant certificates or qualifications are a plus
- Proven track record in preparation and participation of audits and inspections
- Deep Quality Management System Knowledge including GMP principles (e.g., SOPs, Process Controls, etc.) and GCP principles (e.g., Ethical principles, Adequate Drug Information, etc.)
- Experience in latest planning tools (e.g., Microsoft Project) and standard office software proficiency (e.g., MS Office)
- Excellent Project Management Skills and business-professional English language skills
- Decision making skills based on experiential knowledge, paired with strategic thinking and negotiation skills
- Ability to create independent analyses and develop new solutions as well as derive or elaborate suitable next steps in a flexible and changing framework
- Assertiveness and strong communication skills as well as service mentality - stakeholder management on eye level
- Ability to lead various individuals of different professional backgrounds and expertise levels, with with the confidence to be a voice of authority - eager to do what is best for the team and openness to explore new topics/trends
Your Benefits:
- Company Pension Scheme
- Childcare
- Jobticket
- Company Bike
- Special Vacation
... and much more.
Apply now - We look forward to receiving your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on + 49 (0) 6781 9855 220.
Job ID 11841 (please always specify if you have any questions)
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.
Note for applications within Europe: Please note that if you wish to claim travel expenses incurred in connection with an in-person interview, we are obliged to carry out a sanctions list check*. This is carried out by our partner, HireRight. Travel expenses will only be reimbursed if this sanctions list check does not yield any matches. Reimbursement can be made provided that the check is successfully completed.
* Your first name, surname and date of birth will be processed for the sanctions list check. The legal basis for carrying out the sanctions list check for positions at BioNTech in Europe is BioNTech’s legitimate interest. Please note that BioNTech will not carry out the sanctions list check if no travel expenses are to be reimbursed. If you do not give BioNTech your consent to the sanctions list check, your travel expenses cannot be reimbursed. This will not affect your application.