Manager QA Compliance & Validation

☞ Emergent BioSolutions

View: 172

Update day: 26-03-2024

Location: Bern Bern BE

Category: Quality Assurance / Quality Control

Industry: Medical Devices Hospital & Health Care Pharmaceuticals

Position: Mid-Senior level

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 and – Control, Supply Chain and Regulatory affairs working. Approx. 140 professionals are working on the Swiss site of Emergent in Bern / Thörishaus.

We want to strengthen our Quality Assurance team with a

Manager Quality Assurance Compliance & Validation (80 - 100%)

Main Responsibilities
  • Responsible as QA representative in multidisciplinary teams to oversee and review/approve qualification/validation documents and risk assessments for the following topics:
  • Qualification of Equipment, Facilities, Utilities;
  • Computer System Validation (CSV);
In this role the QA Manager drives the implementation of the qualification strategy, supports the transfer from project into commercial production phase, and is the QA representative during FATs and qualification work.
  • Ensures that the allocated quality-systems are compliant with regulatory expectations
  • Establishes and continuously improves quality procedures within the area of responsibility
  • Continuously improves the allocated quality systems
  • Supports changes and corrections for the area of responsibility
  • Participates in audits and inspection within the area of responsibility

Qualification Requirements
  • Master’s degree in Engineering, Biotechnology, or related field.
  • Minimum of 3 years relevant experience in a GxP regulated pharmaceutical/biotechnology industry.
  • Validation and Qualification experience required
  • Solid computer skills including MS Office required.
  • Analytical thinking and problem-solving attitude
  • Multilingual – at least German and English, written and spoken
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Deadline: 10-05-2024

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