Serves as Quality Point of Contact for the IMP release and certification process of the assigned Small and Large molecules including Vaccines.
Serves as a Subject Mater Expert for the assigned Quality Processes.
Assures close collaboration with global Quality departments such as BRQC, PQM, CLS-QA, EQ as well as global Business Partners such as DPDS, VPAD, GCDO and CPU Merksem. Establishes and develops strong working relationships with those departments, including single quality voice regarding IMP QP related topics.
Acts as IMP QP representative for New Product Introductions.
Serves as champion for IMP QP requirements during development of new products, including applying fit-for-purpose strategy on GMP requirements. Applies Quality Risk Management tools in support of smart development.
Leads continued improvement projects and supports strategic projects within the PQM and DPDS environment.
Ensures Quality and Compliance operational targets are met.
Reviews and approves related GMP documents such as procedures and work instructions, investigations, …
Leads and acts as spokesperson during Health Authority inspections and customer audits.
Remains current in knowledge, skills and industry trends.
With focus on Quality activities, develop and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry forums.
Reports Quality trends and makes a positive contribution by making suggestions for improvement. Ensures defined Quality and Compliance improvements are implemented globally.
University degree, Industrial Pharmacist – EU certified Qualified Person is a must.
At least 5 years’ experience in pharmaceutical supply chain and/or quality assurance.
Experience as Qualified Person.
Demonstrated ability to work independently while staying connected with key stakeholders.
Operational Quality and/or Production related expertise is an asset.
Product development expertise is an asset.
Ability to quickly assimilate new technologies, perform risk assessment and develop action plans
In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
Experience with Quality Systems.
Experience with regulatory inspections and preparedness.
Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication and presentation skills across all levels are important.
Understands the business implications regarding quality positions and decisions.