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CMO Quality Lead

Actalent

Posted on Jul 11, 2022 by Actalent

Solothurn, Switzerland
Engineering
Immediate Start
Annual Salary
Contract/Project

CMO Quality Engineer

The main purpose of this job is to manage the Quality Activities with manufacturing and testing partners for assigned products/projects by ensuring quality of product/process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements.

Main Responsibilities

  • Ensure appropriate corrective and preventive actions are defined, implemented and that their effectiveness is assessed
  • Ensure that the CMOs maintain quality systems that are in the state of compliance and aligned with Biogen expectations
  • Able to identify and drive improvements/updates of the GMP documentation related to GEQ activities
  • Ability to successfully influence the peer level at CMOS
  • Train peers, coach other departments on quality regulations and tools

Main Requirements

  • A minimum of 3-5 years of experience in pharmaceutical or biotechnology industries
  • Relevant experience in either manufacturing, development, quality or regulatory; understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies' regulations is a plus)
  • Knowledge of medical device regulations and manufacturing is a plus.
  • Experience in project management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
  • Previous experience in CMO management preferred

If you would like to learn more about this opportunity, feel free to reach out to me directly at (see below)

Job Title: CMO Quality Lead

Location: Solothurn, Switzerland

Job Type: Contract

Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on our website.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Reference: 1664477808

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