Director of Quality Operations, CAR-T
2 days left
- Experience Level
I am seeking a Director of Quality Operations, CAR-T to join my client’s Quality Operations team based in Ghent, Belgium. This person will lead and manage all aspects of Quality in assistance to the Site Quality Head, in support of the cell therapy manufacturing site, in full compliance with established cGMP requirements.
Functions and activities include Quality Assurance review and approval functions, oversight over cell therapy aseptic manufacturing activities, site Quality systems execution, Product and Material Release activities, QC laboratory oversight, etc.
The role develops and implements long-term strategies and execution of Quality programs and manages a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities.
- Manage the daily quality activities for the cell therapy manufacturing site to ensure facility, process, and materials are in compliance with cGMP requirements.
- Partners with other site Quality Heads to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
- Actively participates as a member of the Site Leadership Team, partners with the Site Manufacturing Lead, counterparts and Senior Leaders.
- Develops appropriate operating and capital expense budgets and strives to have the Quality organization contribute to process improvement projects.
- Proactively develops and sustains strong relationships with local/regional/national regulatory authorities.
- Analyzes regulatory authorities’ programs and activities in areas relevant to advanced therapy products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
- Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.
- Manages team of senior managers and professionals within Quality. Hires and develops employees within the department.
- Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.
- Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
- A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required.
- A minimum of 14 years relevant work experience in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
- Working proficiency in English and ideally Dutch
- Knowledge of cGMP regulations and EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
- Strong interpersonal and written/oral communication skills.
- Proven people management and leadership experience is required.
- Experience working with quality systems is required.
- Extensive knowledge of chemical, biochemical and microbiological concepts is required.
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.
- Ability to quickly process complex information and often make critical decisions with limited information.
- Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.
- Proficient in applying process excellence tools and methodologies.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude.
- Good written and verbal communication skills are required.
- Ability to summarize and present results, and experience with team-based collaborations is a requirement.
- Experience developing and setting long-term objectives.
- Ability to identify/remediate gaps in processes or systems
- Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
- Proficient with using Microsoft Office applications
A competitive package is on offer, commensurate with the experience required of the ideal candidate. The role will be based in Ghent, with some flexibility of site and homes-based working.
If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +44(0)1273 952176, or apply with your CV to arrange a confidential discussion.
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