Associate Director CTSM Supply Integration & Integrity

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.