Description
The departmentThe Quality Control department, with approximately 35 employees, is responsible for GMP in-process control, release and stability testing of commercial and clinical biological drug substances and drug products from the Biologics network. This includes GMP management of analytical equipment as well as management of (biological) critical lab reagents needed to perform analytical testing.
The position
Reporting to the Quality Control Lead you will be responsible for leading GMP critical Compliance projects within the Quality Control department. You will functionally report to project sponsor(s).
We are looking for a senior QC person with LSS skills, strong GMP mindset and proven track record within the laboratory space that can deliver projects in time and within budget and is able to energise project team members to get the job done. You must be able to turn complex problems into clear plans and deliverables. Strong communication, ownership of the project and hands-on attitude to get the job done is your second nature
Qualifications
- Bachelor / Masters degree in the field of analytical (bio)chemistry
- Lean Six Sigma (at least green belt) certification
- At least five years of experience with GMP compliance in a QC role within a pharmaceutical (biotech) manufacturing organization
- Strong understanding of deviation control and change control management within Quality Control
- Proven project management skills (leading cross-functional projects > 5 FTE) in a Quality Control environment
- Track record in writing and updating of QC related Standard Operating Procedures and implementing these changes
- Experience with government (FDA, IGZ) GMP inspections
- Strong analytical (eye for detail) & conceptual skills;
- Strong innovative abilities and strong drive to improve;
- Ability to align with all levels in the organisation;
- Strong verbal and written communication skills in both Dutch and English;
- Experience with SAP and LIMS is considered a plus.