Quality Assurance Manager for New Chemical Entities Projects

vor 4 Wochen

Bubendorf, Basel-Land, Schweiz Bachem AG Vollzeit

Bachem AG is a publicly traded, chemistry-focused technology company offering a comprehensive portfolio for the pharmaceutical and biotechnology industries. Our expertise lies in the development of innovative and efficient manufacturing processes and the reliable production of peptide-based pharmaceutical active ingredients. A broad range of biochemicals for research purposes and custom syntheses for our clients complete our offer. With headquarters in Switzerland and branches in Europe and the USA, we operate globally and possess the industry's greatest experience and expertise. In our collaboration with our clients, we attach the highest value to quality, innovation, and partnership.

Quality Assurance Manager for New Chemical Entities Projects (f/m/d), 80-100%

To drive our continuous organic growth, we are constantly seeking highly qualified specialists. To strengthen our team in Quality Assurance III NCE, we are looking for a dedicated Quality Assurance Manager (f/m/d), 80-100%.

Your tasks:

  • Representation of QA in NCE projects at the Bubendorf site.
  • Assessing and deciding on QA-relevant issues in the individual projects.
  • Coordination of project-related tasks within the QA departments and contact person for other departments and areas (e.g., production, quality control, project management) in questions of cGMP compliance and troubleshooting.
  • Define a control strategy and overall project lifecycle strategy for late phase projects including process validation to support the commercial manufacturing phase.
  • Review and approval of GMP documents, changes, deviation reports and CAPA actions.
  • Contact point for our clients for QA-related questions and representation of QA in meetings between Bachem AG and the respective clients.

Your profile:

  • Master or Ph.D. in chemistry, biology, pharmacy, or comparable technical degree.
  • 2 years of professional experience in project management in the chemical / pharmaceutical industry.
  • High level of understanding of broad quality assurance aspects, sound cGMP knowledge (EU-GMP, FDA) and experience in accompanying process validations incl. risk management.
  • Particularly good verbal and written communication skills in German and English.
  • High level of comprehension and a structured personality capable of making decisions.
  • Resilient, service-oriented, communicative, and flexible personality with the ability to present complex events and contexts in an understandable way and to communicate internally and externally.

Our offer:

  • A dynamic and fast-growing working environment with internal development opportunities.
  • Flexible working hours with the possibility of working from home and the option to take additional vacation days with a reduced workload.
  • Employee development through various internal and external training opportunities.
  • 60 % of pension fund contributions paid by Bachem AG as well as the option of extra-mandatory pension provision with our optional savings plan.
  • Access to the Swibeco benefits platform with discounts from external partners.

We are looking for a dedicated professional to drive innovation together with us.

Do you have a passion for quality assurance and a desire to work in a dynamic environment? Then we look forward to receiving your complete application documents via our application portal.

Learn more about the Bachem Group and be inspired by our inspiring working environment at our site in Bubendorf

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