Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $40B and 100,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. We give our people the resources and opportunities to make significant contributions to the world.
At our site in Groningen we offer our clients a full-service s to obtain all approvals to produce bio-pharmaceuticals on a commercial level, including biologic manufacturing under full cGMP conditions, compliant to client requirements.
Site Quality Head, Groningen, Netherlands
You will be reporting directly to the Head of Quality Biologics and dotted line to the General Manager for the site, leads, directs and manages the site’s Quality organization and departments and all Quality related programs and activities to support site operations for clinical and commercial manufacturing, testing, and release of biopharmaceutical products. The Quality department (Quality Assurance and Quality Control) consist of over 80 colleagues and you will be managing several hierarchical layers of departments as well as areas of expertise.
How will you make an impact?
As the Site Quality Head you ensure business, quality and compliance goals are met and in compliance to Global Quality policies and standards and relevant government issued quality and regulatory policies/ guidelines.
You will also be responsible for ensuring a comprehensive, robust and effective Pharmaceutical Quality system is in place and implemented throughout the organization.
In this role you will able to demonstrate continual improvement mindset with strong customer focus. It's a true leadership position that will develop Quality strategy, make decisions based on relevant data and current Good Manufacturing Practices (cGMPs).
What will you do?
Responsible for ensuring that each batch of medicinal product has been manufactured and checked in compliance with the local/ regional/ national/ international laws in force and in accordance with requirements of the Marketing Authorisation, as required.
Responsible for the approval or rejection of starting materials, intermediate, bulk, and finished products, ensuring that all necessary testing is carried out and the associated records evaluated including the approval of specifications, sampling instructions, test methods and other Quality Control procedures including the approval and monitoring of any contract analysts
Proactively develop and sustain strong relationships with local/regional/national regulatory authorities. Represent the site/company in all written and face to face communications with the regulatory authorities.
Analyze regulatory authorities programs’ and activities in areas relevant to biological 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.
Manage a team of managers and professionals within Quality. Hires and develops employees within the department in support of Human Resources Planning. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
Manage the performance of the team through effective key performance indicators, targets and goal settings.
Leads, coaches and motivates members of the team on a positive basis. Works with and advises staff on administrative policies and procedures.
Accountable for reviewing and responding to escalated customer product quality queries or issues to customer satisfaction.
Advise SLT on new technologies which are relevant to the department which may offer more cost effective, robust solutions to the business.
What do you need?
Bachelors degree in a scientific/technical subject area with 10+ years shown experience in a quality leadership position, or >15 years management experience with GMP responsibilities within the biological and/or pharmaceutical industry
Significant experience in supporting functional areas (e.g., R&D, Manufacturing, QC, Engineering, EHS, Tech Services) preferred
Excellent interpersonal skills
Ability to multitask, strategically and tactically
Validated knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.
GMP regulations and international guidelines to all aspects of the position
Validated leadership in leading sophisticated regulatory topics and interactions