BioTalent has teamed up with dynamic and innovative clinical trails partner & supplier inBerlinon their search for anQA Associate Director/ Qualified Person.In this position you will be responsible for leading the quality assurance team in Berlin. You’ll also ensure the organisation meets local regulatory requirements and client expectations, whilst collaborating closely with global teams in the USA, UK, and France.
You will be responsible for:
Lead and manage all quality assurance activities at the Berlin site
Ensure compliance with local and global SOPs and regulatory requirements
Act as a mentor for the QA and QC teams, supporting daily quality tasks and initiatives
Oversee external audits and regulatory inspections
Develop metrics and KPIs to assess compliance and drive continuous improvement
Create, review, and approve quality-related documents
Manage deviations, customer complaints, CAPAs, and risk management processes
Serve as the company’s Narcotics Officer
You will bring the following:
You must be a registered Qualified Person in the EU
Strong understanding of Quality Assurance within the life science industry
You must have business level fluency inGerman&English