Associate Director, QA Operations

vor 7 Stunden


Bern, Schweiz Emergent Biosolutions Vollzeit

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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