SENIOR QA MANAGER
Functieomschrijving
The Senior Quality Assurance Manager provides QA and business oversight while managing day-to-day QA operations.
You are accountable for execution of QA processes including complaints, corrective and preventive actions, change management, internal audits, external audits, supplier management, management review, and quality agreements.
You are responsible for ensuring the business location’s compliance with applicable regulations and ISO standards.
You are a QA subject matter expert and technical resource for QA staff and internal teams.
You are a member of the local management team. You lead and develop others to increase the company’s leadership bench.
Additionally, you are accountable for ensuring that the training and development needs of your team are addressed.
Profiel
- You have a Master or PhD in Sciences or similar field or equivalent by experience;
- You have already worked with several quality systems in the biomedical or pharmaceutical sector (ISO9001, ISO17025, ISO13485, ISO15189 EU cGMP, OECD GLP, 21CRF58, etc ...) ideally in a contract lab organization;
- You have knowledge of, and experience with common principles around device and system qualification within a regulated framework (cGxP, 21CFR11, GAMP 5, EU GMP Annex15, etc.);
- Knowledge of regulatory and industry requirements around IT systems;
- You speak and write Dutch and English very well since all our communication is in Dutch and English. Knowledge of French is a plus.
- You are inherently incorruptible and accurate in the things you do;
- You have people management and leadership skills;
- You are committed, dynamic, customer focused and stress resistant;
- You can put yourself into perspective and function well within a global context;
- You identify opportunities for improvement and are able to lead change.
Aanbod
You will come on board full-time, but you can divide your time between office and home work (2 days per week). We also work with sliding working hours which offers you great flexibility. Your commitment will be rewarded with a matching salary that is complemented by a nice benefits package including meal vouchers, group, hospitalization and ambulatory insurance, lease bicycle, home office allowance, net allowance, company car, ... . Nelson Labs is located in the industrial zone of Haasrode which makes us easily accessible by car, public transport and bicycle. If you come by (electric) bike, you can park it safely in our covered bicycle parking area, where you can also power your electric bike.