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GxP QA Compliance Manager for Quality Assurance

Exciting opportunity in an innovative biopharmaceutical company

 

Our client is looking for a skilled QA manager with a strong interest in Quality Compliance to join their Quality department. The position has a broad variety of responsibility across the GxP areas from development through clinical and to final market release i.e., GLP, GCP, GMP, GDP and GVP.

You will be part of the Quality department together with the QMS Manager and the Head of Quality Assurance. You will in close collaboration with your quality team members assist building a culture of quality and support the strategic direction of the Quality Management System (QMS) and ensure that the Quality System is in a state of control.

With direct report to the Head of Quality Assurance.

Your main tasks are:

  • Quality oversight in all GxP activities
  • Provide professional expertise and guidance on GxP and applicable regulations
  • Provide advice internally and externally on GxP quality matters
  • Review and evaluate the quality of CROs and vendors
  • QA Support to other functions and areas
  • Identify and contribute to best practice and continuous improvements across the organization
  • QMS System management for quality documents and training in collaboration with QMS Manager
  • Management of quality Deviations, CAPAs, and Change Requests
  • Participation as lead or co-host in internal audits and audits of CROs and vendors
  • Develop and maintain audit tools and strategies
  • Ensure inspection readiness in collaboration with functional areas
  • Support GxP teams in preparation for inspections and co-host authority inspections
  • Surveillance of GxP regulations and guidelines
  • KPI reporting to Quality Management Review
  • Participation in cross-functional projects

Your qualifications are several years of experience from the pharmaceutical industry within Quality Assurance preferably together with GCP-related and/or GVP relevant Quality Assurance experience. You have a proven track-record of maintaining quality systems and electronic systems in a pharma organization. You have participated in regulatory inspections and experience in conducting audits.

You have a relevant scientific educational background, but your experience is more important.

You are a person with a can-do attitude, who is able to navigate across the organization and adapt to changes. Moreover, you possess strong communication skills and are able to create strong relations with both internal and external stakeholders. 

Our client offers an exciting opportunity to join an innovative company with dedicated employees and with room for both professional and personal development.

Domicile: Copenhagen.

For more details about the job or the company, please contact Senior Consultant Belinda Bramsnæs, Unique Human Capital on M: +45 28 44 28 44. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
/ /
cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
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