Commercial Quality Assurance Manager & Responsible Person Benelux

Our people in Manufacturing & Global Operations share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of collaboration. Together, we make sure our products meet the highest standards of quality by constantly searching for ways to improve at every stage of our value chain – in this case acting as the QA Manager in our Affiliate to assure GDP compliance for our products. Join our team and help us make an even bigger contribution to Grünenthal’s future.

What the job looks like
You will work as Commercial QA Manager Benelux and Responsible Person GDP & Narcotics Benelux within the Sales Affiliates in Belgium and the Netherlands, and will report to the Head of CQA Europe in our headquarters. It is possible to work hybrid, with a minimum of 2 days per week in the Belgian office.

Each day you'll enjoy a variety of challenges, such as:

• Assume overall responsibility related to storage, distribution and wholesale activities of medicinal products as required by GDP guideline:

  • Maintaining Wholesale Licenses and Narcotic Permits for the sales affiliates BeLux & NL 

  • Ensuring that a quality management system is implemented and maintained

  • Ensuring that initial and continuous training programs are implemented and maintained

  • Coordinating and promptly performing any recall operations for medicinal products

  • Ensuring that relevant customer complaints are dealt with effectively

  • Ensuring that suppliers and customers are approved

  • Approving any subcontracted activities which may impact on GDP

  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programmed and necessary corrective measures are put in place

  • Deciding on the final disposition of returned, rejected, recalled or falsified products

  • Ensuring that additional requirements imposed on narcotic products by national laws are adhered to

• Assure support to the maintenance and development of the global QMS in the affiliates:

  • Implementing all GDP-regulated activities, based on the Global PQS of Grünenthal, including:

    • Overview and maintenance of the Commercial Affiliate specific QMS system (PQR, handling of Change control management, deviations, quality complaints, recall and mock recall execution)

    • Assure KPIs reporting

    • GDP batch verification for commercialized finished products

  • Regular meetings with the Third Party Logistics providers in Belgium and the Netherlands

  • Participation in audits and inspections at the sales affiliates BeLux & NL

  • Driving QA initiatives and supporting cross-functionally all functions and departments to successfully contribute to business continuity and expansion objectives.

  • Ad-hoc membership in decision bodies and major internal working groups, such as Local Management Review and Local Crisis Management. 

What you'll bring to the table
To make the most of this role and truly thrive, you should have the following competencies/skills/education:

• Fluent in Business English, fluent in Dutch, sufficient level of French

• Master or bachelor in (Industrial/Hospital) Pharmacy or (Bio) Medical Science

• Proven expertise in QA with 5 years of experience in GMPs/GDPs in pharmaceutical industry

• Leading change & acting as entrepreneur

• Global perspective & Intercultural sensitivity

• Strong interpersonal understanding & communication skills.

• Creativity and flexibility are just as important as high motivation and being a self-starter

______________________________________

"In this position you will be part of the Commercial Quality Assurance Europe Team and the Commercial Benelux Organization." Ana Gabriela Estrella Davila, the Hiring Manager