Associate Director, QA Operations

☞ Emergent BioSolutions

View: 170

Update day: 26-03-2024

Location: Bern Bern BE

Category: Quality Assurance / Quality Control

Industry: Medical Devices Hospital & Health Care Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life. As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats. We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

At Emergent BioSolutions Berna, the Swiss affiliate there are - beside manufacturing activities – professionals in Quality Assurance, Quality Control, Supply Chain and Regulatory affairs working. On the Swiss site of Emergent in Thörishaus / Bern there is approx. 140 dedicated and committed professionals working locally and globally.

Emergent is looking to recruit an experienced professional into the role of

Associate Director Quality Assurance (f/m) 100%

Position Summary

The Associate Director Quality Assurance (QA) will lead the QA Operations Team with 3 - 4 direct reports and act as QP delegate for technical and market batch release and certification

Main Responsibilities
  • Organizational and personnel lead of the QA Operations team in Thörishaus
  • Batch Record Review, technical release of raw materials, intermediates and final product
  • Market release and certification of final product for the Swiss Market
  • Site expert for QMS processes and operational QMS management
  • Site representation in global QMS projects and implementation of global initiatives at the site
  • Definition and management of material and product specifications
  • Management of customer complaints
  • Management of recalls
  • Product Quality Reviews and KPI reporting
  • Active participation in inspections and audits

Our Requirements
  • University degree in natural science, medicine, or pharmacy
  • Minimum five years’ experience in GMP-regulated industry, preferably in a QA/QC position
  • Leadership experience is a plus
  • Self-confident and strong interpersonal skills, well able to manage all types of stakeholders and situations
  • Able to work with a high degree of autonomy and self-management, being able to proactively find solution to issues and knowing when to escalate
  • Excellent verbal and written communication skills in English and German
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Deadline: 10-05-2024

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