Powering life sciences
through talent
Introducing Panda Intelligence: Your Recruitment Partner in the Intricate World of Data and AI in Life Sciences
Return to search results

Sr. Quality Associate - Compliance

Sr. Quality Associate - Compliance

LocationBreda, Netherlands
Business SectorBiotechnology
Contact email
Job ref22163
Publishedabout 1 month ago

Sr. Supply Chain Associate - Compliance

Embed the principles of Good Distribution Practices guideline (2013/C 343/01) in the EU Regional Supply Chain network, to ensure that product quality is maintained.
Embed the principles of the Falsified Medicines Directive (2011/62/EU) in the EU Regional Supply Chain network, to ensure that the authenticity of Amgen product is maintained.


  • Own and manage temperature assessment records (CTETS)
  • Own and manage minor and major deviation records and lead root cause analysis sessions
  • Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
  • Manage missing product notifications, including leading Event Review Team meetings if applicable.
  • Support audits and inspections involving EU supply chain, including audits and inspections at the affiliate level.
  • Support activities for product recall or annual mock recall exercises.
  • Incidental travel might be required.
  • Ensure up to date smartsheets for minor, major, CTETS and missing products
  • Own the supply Chain Distribution manual
  • SME for document management control

Minimum Requirements

  • Bachelor’s degree or equivalent in Life Sciences + 2 years’ experience in GMP / GDP compliance
  • In the absence of a Life Sciences degree, 4+ years’ experience in GMP / GDP compliance
  • Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
  • Fluency in English; Dutch is a nice to have
  • Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. Trackwise, EDMQ, etc)

Preferred Requirements

  • Experience in audit / inspection support
  • Technical writing skills


  • Effective communication skills at multiple levels, areas and countries
  • Ability to apply risk-based approach, making decisions and escalating issues appropriately
  • Analytical and evidence-based approach to problems.
  • Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together.
  • Pro-active in proposing solutions and driving tasks to completion
  • Works autonomously, respecting deadlines
  • Works with a high degree of discipline and attention to detail


  • Location: Breda, NL
  • Duration: 1 year with the possibility of extension 
  • Start-date: ASAP 
  • Hybrid working

Sound interesting?
Please send your CV to Khanyi Mabena at k.mabena@panda-int.com or call her on +31 2020 44502.