Overview
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.
Quality Manager for Microbiology Manufacturing (m/f/d)
Location: Wesel, Germany
Location/Division Specific Information
Oxoid Deutschland GmbH, part of the Thermo Fisher Scientific Group, is a production, sales and service site with approximately 240 employees. The SDG (Specialty Diagnostics Group) business area, which includes the Microbiology Division, manufactures products that are used for microbiological applications in clinical laboratories for the diagnosis of infectious diseases and are used in food and pharmaceutical companies to ensure that their products and production facilities are free of microbial contamination.
Discover Impactful Work:
Provide leadership and management for quality activities at the Microbiology manufacturing site in Wesel (Germany) to ensure that quality assurance, quality systems, product performance testing and quality engineering activities are effective, efficient and in compliance with regulatory expectation and quality standards.
A day in the Life:
Responsible for compliance to mandatory regulatory requirements including Quality Management Systems standards i.e. DIN EN ISO 9001, DIN EN ISO 13485; DIN EN IEC 17025, FDA and the In Vitro IVDD, IVDR
Drive continuous improvement through PPI to deliver improved performance from a quality, service and cost point of view.
Responsible for the release of product to external and internal acceptance criteria.
Set clear comprehensive expectation demonstrate role model leadership; provide meaningful, timely feedback about performance, train and mentor to continuously improve individual performance and business results
Prepare and monitor site quality objectives and provide metrics and quality input to the Site Senior Leadership team and the Divisional QRA function
Prepare the site for, and host external audits (customer/regulatory) ensuring corrective/preventative action are put in place to address non-conformances.
Drive, champion and promote quality practices and behaviours across the site.
Lead and develop staff within the function to a high level of competency and performance.
Key repsonsibilites:
Responsible for compliance to mandatory regulatory requirements including Quality Management Systems
Manage fundamental quality system process to ensure compliance, timeliness and effectiveness e.g. CAOA, change control, audit, management review, supplier control, etc.
Ensure that all customer complaints are reviewed in a timely manner and escalated appropriately through the vigilance process where required, including notification of reportable events to regulatory authorities.
Prepare the site for, and host external audits (customer/regulatory) ensuring corrective/preventative action are put in place to address non-conformances.
Review ongoing development of the Quality System to ensure and improve its effectiveness through ownership of the management review process.
Lead the quality engineering team ensuring partnership with the Operations teams on production issues, training and SOP compliance, root cause analysis, CAPA implementation and other Quality related matters
Keys to Success:
Education
Degree in a Biological Science or QA field
Experience
Five years management experience in an IVD Quality Assurance / environment
Experience in microbiology
Managerial Experience
Knowledge, Skills, Abilities
Knowledge of regulatory requirements including ISO 13485, 9001, 17025 and the IVDD and IVDR
Electronic QMS systems
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
Are you interested?
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 contribute 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.
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