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Manager QA Compliance & Validation

Location: 

Bern, CH

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

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.