Qualified Person & QA Manager

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. Netherlands
Amsterdam, Netherlands
Posting date: 25 Nov 2020

An innovative pharmaceutical company Located in Amsterdam (NL) is in search for a talented Qualified Person & QA Manager who will report to the Head Product Release and Distribution Quality Assurance (QA). The selected candidate will act as an EU Qualified Person (QP) for investigational and commercial medicinal product, as well as oversee the operational QA activities related to batch release of drug products and combination products within the EU region.

Job Responsibilities

  • As a Qualified Person (QP) responsible for the certification and release of commercial and investigational medicinal products (IMPs) for the European market and clinical studies in EU according to applicable GMP directives, regulations and guidelines
  • Perform and participate in internal/external audits
  • Review IMPDs, MAAs and other CMC/technical documents as needed
  • Manage third parties (e.g. manufacturing/packaging sites, logistic service providers, distributors etc.) located in the CEMEA region including qualification, auditing and contracting activities
  • Support the maintenance and improvement of the Quality Management System for Alnylam Netherlands and for supporting the CEMEA QMS acc. to applicable local, regional and global directives, regulations and GxP guidelines
  • Support operational QA activities including the handling of deviations, CAPAs, change controls, complaints, temperature excursions, quality issues and recalls
  • Provide Quality support to Alnylam affiliates in the CEMEA region including inspection management, maintenance of an adequate Quality Management System and management of intra-company Quality Agreements
  • Support the timely execution of qualification/validation of shipping systems and new lane assessments in support of the business
  • Support new product launches
  • Support and lead local and regional projects

Skills and Requirements

  • At a professional level, we are seeking an individual with significant experience in a Quality Assurance role, including as a QP, within the biotechnology or pharmaceutical industry
  • Ideally, this individual will have gained experience with commercial as well as investigational medicinal products as well as medical devices/combination products
  • BSc, MSc or Ph.D. preferably in Life Sciences (e.g. Pharmacy, Biology or Chemistry);
  • Registered QP in The Netherlands with demonstrated experience with the certification and release of investigational and/or commercial medicinal products;
  • Pharmaceutical industry experience in various QA or QC and possibly manufacturing roles;
  • Sound knowledge of pharmaceutical GxP processes and regulatory requirements related to IMPs and commercial products
  • Experience as a GMP/GDP Auditor preferred
  • Ability to drive and manage issues, complaints, CAPAs and changes through to satisfactory conclusion
  • Fluent in written and spoken English and possibly Dutch, additional languages are a plus;
  • Ability to communicate effectively through verbal and written media;
  • Ability to interact with personnel of all levels, including customers;
  • Strong interpersonal, influencing and listening skills
  • Sense of urgency; ability to recognize time sensitivity and lead
  • Ability to work as a true team player and be effective in a collaborative culture
  • Responsive and "quick-on-their-feet" when experiencing changes
  • Has the confidence to make decisions with authority and with the full understanding of the potential down-stream consequences

To Apply

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