Are you an ambitious, inspirational leader with strong expertise in QA management, gained in a GMP-regulated Biotech, Pharmaceutical or ATMP environment? A brand-new role has been created with a pioneering cell therapy and regenerative medicine organisation in Oss, Netherlands. We are looking for an experienced Quality Assurance Manager with a pragmatic approach to Quality, given the different variables of Cell Therapy which make it naturally less accurate than small molecule / traditional Pharmaceuticals.
Based in the South East of the Netherlands, this could be a great career move for someone looking to move to a beautiful part of the country and join an innovative, growing organisation. You will be paid a very generous salary (around €7,500/month gross, or €90,000 annual pre-tax), plus excellent benefits (pension, stock options, travel allowance etc) and the company will provide financial support (and sponsorship if needed) to people relocating from other countries. You must be fluent in English.
This is a genuinely exciting, varied opportunity for an ambitious individual with strong leadership skills and positive energy. If you are a QP, or have commenced your QP training, this would be a significant advantage.
The Company
An innovative cell therapy organisation that has grown from 7 to 40 people in the last 3 years. With their first product in clinical trials, a new facility planned in 2023, and a healthy pipeline of funding, the company is busy, forward-thinking and highly supportive of new ideas. The business is based on amazing science, providing an alternative to T-cell therapy. With around 30 different nationalities across the business, they pride themselves on their supportive and inclusive working culture.
The Role
You will have a broad range of responsibilities including:
Managing all aspects of QA systems for a phase I to commercial GMP cell therapy manufacturing facility.
Responsible for managing the QA department in a fast-growing environment (work planning, staffing and training, review and approval of batch/unit records).
Consulting with CEO on decisions to ensure alignment and agreement.
Reviewing and approving SOPs, forms, protocols and reports, as well as equipment qualifications.
Ensuring changes are justified and procedures are followed.
Reviewing and approving deviations, CAPAs and change controls and partnering with other departments on these topics as the Quality expert.
Ensuring vendor management program is in place and support all Glycostem operations.
Ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).
Overseeing clinical shipments
Additionally, if you are a QP then you will perform final release of products, and / or manage contract QPs. If you are not yet a QP, this will be an excellent role in which to gain experience to support your QP training.
This is a genuinely unique, busy and exciting role with many different aspects, presenting a real opportunity to progress to the next phase of your career. Full details, including a comprehensive job spec, will be provided on application.
Experience
The successful candidate will ideally have a degree (or higher) in a bioscience discipline (cell biology, biotechnology, biochemistry, microbiology etc), together with experience in a leadership role gained in a GMP-regulated QA environment. Experience in a cell biology, human cell culturing, stem cell or other biologics environment would be an advantage, but equally we will consider people with more traditional Pharmaceutical or Biopharmaceutical experience if you can show a pragmatic approach to Quality within a less accurate scientific setting.
You will need to be able to demonstrate excellent leadership skills and experience, gained in a managerial capacity within a regulated, process-led environment. You must be able to demonstrate the ability to learn, listen actively to others, and build collaborative relationships.
This is a permanent role in the Netherlands. Candidates will be invited to relocate from the UK or EU countries, provided you speak a high level of English.