AD of QA

BioTalent Ltd; Deutschland; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A leading life sciences consultancy in Berlin seeks a QA Associate Director/Qualified Person to lead the quality assurance team. Responsibilities include managing compliance with regulatory requirements, mentoring staff, and overseeing quality-related documentation. The ideal candidate must be a registered Qualified Person in the EU, possess strong QA knowledge in the life sciences sector, and be fluent in both German and English. This position offers a pivotal role in ensuring high-quality standards.

Qualifikationen

• Must be a registered Qualified Person in the EU.
• Strong understanding of Quality Assurance within the life science industry.
• Business level fluency in German and English.
• Previous experience in Line Management.

Aufgaben

• Lead and manage all quality assurance activities at the Berlin site.
• Ensure compliance with local and global SOPs and regulatory requirements.
• Mentor QA and QC teams, supporting daily quality tasks.
• Oversee external audits and regulatory inspections.
• Develop metrics and KPIs for compliance and improvement.
• Create, review, and approve quality-related documents.
• Manage deviations, customer complaints, CAPAs, and risk management processes.
• Serve as the company’s Narcotics Officer.

Kenntnisse

Leadership in QA

Regulatory compliance

Fluency in German

Fluency in English

Ausbildung

Registered Qualified Person in the EU

Jobbeschreibung

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
• Previous experience in Line Management