Quality Assurance Manager & Responsible Person Delegate

Ferring Pharmaceuticals

Hoofddorp, Netherlands

In this position, you will be responsible for maintaining FPBV Distribution Quality Systems, ensure inspection readiness at all times and provide adequate and timely responses to observations and follow-up on CAPA implementation.

You will assist Health Authority inspections at FPBV and distribution centers and support GXP surveillance and assessment of new regulations where appropriate and required.

We also expect that you act as “Responsible Person Delegate” for FPBV. Furthermore, you will be responsible for performing post-certification disposition of batches to be released, quarantined, or rejected upon instruction from Global QA teams or releasing sites.

Your day at Ferring

Writing GDP related SOP’s and manage the administration of GDP documentation and records.
Ensuring adequate processes and procedures are in place to facilitate the verification of medical products and any other requirements that may impact GDP activities.
Assisting in the approval of suppliers, customers and third parties’ activities related to the distribution of our products.
Managing and optimizing technical agreements between FPBV and third-party customers.
Managing Ferring’s Distribution Centers at a regional and a global level.
Performing quality assessment of deviations derived from storage and transportation processes and ensuring effective corrections and CAPA’s are well established and implemented.
Monitoring quality mailboxes and QMS’s for releases and follow-up with relevant departments.
Performing quality audits regarding Logistic Service Providers and third-party customers as per compliance and business needs.
Acting as “Responsible Person Delegate” for FPBV.
In the role of Responsible Person Delegate, decide on the final disposition regarding returned, rejected, and falsified medical products, including any decision on returning to saleable stock.
Supporting the continuous improvement of the QMS.

Behind our innovation…There’s you

University Degree in Pharmacy, Chemistry or Biology.
7 years of experience as a QA Manager and/or Responsible Person (Delegate) in the Pharmaceutical Industry.
Sound knowledge and experience in Quality Assurance and Regulatory Inspections.
Good ability to work with Quality Management Systems.
Experience managing Pharmaceutical distributors and in the EU distribution compliance guidelines.
Strong experience in GDP inspections and audits.
Excellent proficiency in English. Spanish is an advantage.
Good communication skills and cultural awareness.
Experience in Project Management.
Able to multitask, organize and prioritize under time constraints.
Strong team player skills and the ability to work and thrive in a complex matrix environment.