Quality Systems Management Manager (m/f/d)

REFERENCE NUMBER:

559009/1

MY DUTIES:

- Drive activities to support the readiness of the QMS and supporting business processes for the start-up of GMP production in Solothurn
- Support GMP operations as well as ongoing expansion projects in a paperless environment
- Responsible to drive continuous improvement activities in the area of quality
- Serve as site liaison to global functions for documentation, training, and corporate quality systems e.g., change control, CAPA, quality risk management, data integrity and exception management
- Support site governance teams such as Management Review, Quality Exceptions review board, Change Control Review board, QMS implementation, Inspection Readiness and Inspection Management Support in providing quality key performance indicators
- Build partnership with the global quality organization and corresponding partner site in US to ensure local implementation of the global QMS
- Manage the Quality Risk Review Process at the Solothurn site
- Lead selected activities to ensure the local implementation of Biogen global quality systems at the Solothurn Site through current state of construction through commissioning, validation, regulatory approval and into daily GMP operations

MY QUALIFICATIONS:

- Bachelor’s Degree or master’s degree in Life Science preferred
- Profound experience in pharmaceutical or biotech manufacturing environment
- Prior experience with fully electronic operations and management is preferred
- Fluency in English is required
- Prior experience with facility construction and start-up strongly preferred
- Proficiencies with the Quality systems and business processes associated
- Demonstrated ability to work autonomously and to lead project teams in a matrix organization
- Project Management experience is required
- Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors, and external partners effectively

MY BENEFITS:

- You will work in an international environment

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Emina Mustafic

Reference number
559009/1

Contact
E-Mail: [email protected]