Vacancy Senior Manager QA, EU QP – Utrecht


Organization

For a global organisation in the pharmaceutical market that focuses on, among other things, cell therapy, we are looking for a Senior Manager QA, EU QP.

Function

In this position as Senior Manager QA, EU QP you are responsible for the implementation, organisation, management and execution of the quality assurance function and the QMS. As a QP, you have full authority to make decisions regarding product quality, safety, purity and efficacy, independent of other business interests.

Activities

  • Interpret and apply international, regional and local regulations within the GMP/GDP environment and batch processing in the EU
  • Interaction with global surveillance, location and supplier surveillance
  • Participate in GMP or GDP related health authority inspections as needed, respond to all recorded observations and ensure implementation of corrective actions
  • Managing quality and compliance risks by performing risk assessments and ensuring mitigation actions are taken
  • Participate in optimising a delivery process that takes into account the specificities of phased-release autologous cell therapy treatments, treatment of OOS results and related risk assessments
  • Conduct final review and approval of non-routine quality investigations related to batch variances, batch disposition and other quality systems for assigned products
  • Identify and recommend product and process quality improvements
  • Support and maintain and continuously improve the quality management system
  • Draft or review, negotiate with contractors and recommend approval for quality agreements
  • Conducting internal audits and supporting external GMP/GDP site inspections
  • Disposition (release/denial) batches of drugs/substances

Requirements

You are the ideal candidate if you meet the following requirements:

  • You have completed a BSc degree in a technical or scientific direction
  • Extensive pharmaceutical quality assurance/control experience (equivalent to a minimum of 5 years experience), including audit, batch record control, change control, complaint handling and investigation experience
  • You are eligible to act as a qualified person within the EU
  • You have excellent communication skills, including excellent written, interpersonal, collaboration, negotiation and dispute resolution skills, with a team-oriented approach
  • You have excellent organisational, project management and problem-solving skills
  • You understand processes and interactions that are essential for ensuring and enforcing regulatory compliance

Offer

This organisation can offer you the following:

  • Annual salary between €70,000 – €100,000 based on knowledge and experience
  • A bonus between 10% and 15 %
  • A car scheme
  • Excellent pension
  • Good secondary employment conditions

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Romy Snijder
Associate | Biotech/Pharma division

+31 6 58 81 46 32
+31 23 754 86 60
r.snijder@qtcrecruitment.com