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QA Manager Biologics

  • Job type: Permanent
  • Location: Amsterdam
  • Salary: Competitive
  • Job reference: GS - 69
  • Sector: EPM Scientific, Quality
  • Date posted: 15/09/2017
QA Manager Biologics


My client has recently acquired a biologics division to add to their vast product portfolio. They are a Global Pharmaceutical company and looking for dedicated QA resources to ensure QA compliance in their growing global external Biologics activities. The QA manager Biologics ensures oversight and quality compliance in all of my client’s biological products manufactured externally worldwide. This includes technical development and commercial operations.


This position is in the Corporate QA Biologics and CM Department and will report into Head Corporate QA Biologics and CM. There is also an expectation of 10% to 15% of international travel.


 
Key responsibilities


  • Support launch of the Biologics products with regards to compliance with QA requirements and their implementation. This includes qualification, management and exiting/transferring activities of CMO’s in line with the clients Quality Management System.
  • Prioritizes and manages Biologics CMO related QA topics and action items. The main point of contact for all QA related topics.
  • Manage all QAA’s with CMOs and participates in contract negotiations, audits, disputes, and supply agreements.
  • Manage (initiate and investigate) all significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
  • Provides support for regulatory agency inspections and requests. Interact directly with CMO’s to resolve quality issues.
  • Maintains awareness of current GMP trends and manufacturing processes and supports continuous improvement within the QA Biologics and CM department.
 

Requirements

  • Bachelor Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
  • Minimum of 5 years of relevant experience in biopharmaceutical Drug Substance and/or Drug Product manufacturing.
  • Advanced knowledge and experience in pharmaceutical operations, QA/QC processes, and contract manufacturing.
  • Strong cGMP experience and knowledge, QA/QC and regulatory compliance (US, EU, and other international agencies)
  • Strong interpersonal skills, excellent communication skills, good presentation, negotiation and influencing skills
  • Ability to effectively manage multiple, complex priorities.
  • Team player, task-oriented and keen on working in a cross-cultural working environment.


 If this of interest to you, please reply to the following contact details;

apply.a33ho1giadc@epmscientific.aptrack.co.uk


+442036678356


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