Manager, Quality Assurance Operations

vor 1 Woche

Bern, Schweiz Emergent Biosolutions Vollzeit

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 support the Quality Assurance (QA) Operations Team with a

QA Operations Manager (f/m) 100%

**Main Responsibilities**:
Batch Record Review, technical release of raw materials, intermediates, and final product
Preparation of market release and certification of final product for the Swiss Market
Quality assurance of deviations, CAPA, change control and complaints
Quality assurance and authoring of controlled documents
Site representation in global QMS projects and implementation of global initiatives at the site
Management of raw material and product specifications
Product Quality Reviews and KPI reporting
Training of site employees
Active participation in inspections and audits

**Our Requirements**:
University degree in natural science, medicine, or pharmacy
Minimum three years’ experience in GMP-regulated industry, preferably in a QA/QC position
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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