Senior Quality Manager, EMEA (m/f/d)

Job content

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Discover Impactful Work:

The purpose of this role is to develop, maintain and lead quality management, quality assurance activities and ISO accreditations primarily in Europe. Develop, deploy and drive alignment, harmonization and QMS (Quality Management System) compliance of ULS (Unity Lab Services) processes and activities

The main responsibilities of this position are:

• Development, deployment and maintenance of QMS
• Use input from the EMEA ULS leadership team and other collaborators, to define strategic roadmap for the European QMS development as well as ISO certification standards.
• Gain and maintain required ISO certifications per defined business requirements.
• Develop, deploy and drive processes to ensure regulatory compliance as applicable and improvement of the quality of product and services delivered by the organization i.e CAPA; Complaints, Risk management, supplier qualification, etc, (not all inclusive listed here)
• Ensure alignment with global: Quality systems, COE Documentation, and corporate guidelines and policies.
• Promote organization’s quality policy and ensure alignment with QMS and certification standards.
• Cultivate quality culture development within the organization
• Be the appointed quality representative of the EMEA QMS
• Lead the European Quality team
• Support and guide the EMEA ULS leadership team for quality and regulatory related matters
• Support and facilitate development and harmonization of global processes.
• Get along with ULS partner organizations (Factories, product lines, etc) quality leaders and organization to develop vital interfaces
• Interact with Corporate QA/RA Leadership team to represent ULS Quality
  
  

Keys to Success:

Education

• Bachelor degree minimum and prefer Master’s degree level or equivalent experience
  
  

Experience

• Proven tracked experience of more than 10 years in a quality management lead position preferably in equipment and Life Science industries
  
  

Knowledge, Skills, Abilities

• In depth knowledge of ISO9001, ISO13485
• Knowledge and understanding of GxP regulations especially within the Pharmaceutical industry
• Knowledge of clinical regulations
• Knowledge and understanding of ISO17025, ISO14001, OHSAS 18001
• Fluency in English is preferred. Additional languages are an asset (German, French)
• Strong commercial competence and customer centric
• Strong interpersonal and self motivational skills are crucial
• Excellent verbal and written communication skills, ability to work across all levels, functions and regions in complex matrix organization
• Willingness to travel
• MS office and IT system literate
• Master Control (document control systems) proficient
  
  

What we offer:

• Employment with an innovative, future-oriented organisation
• Outstanding career and development prospects
• Company pension scheme and other fringe benefits
• Exciting company culture which stands for integrity, intensity, involvement and innovation
  
  

If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and chip in to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.

Apply today! http://jobs.thermofisher.com

Agency notice!

Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.