Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Location/Division Specific Information:
Phadia GmbH in Freiburg is the German branch of Thermo Fisher Scientific's Immunodiagnostics division. We develop and distribute allergy and autoimmune diagnostics.
How will you make an impact?
Take on the role of Product Care Manager in Research & Development to ensure top-tier products. Your impact includes implementing outstanding care strategies and collaborating with diverse experts.
A Day in the Life:
Lead and cooperate across teams to manage post-launch products for Autoimmunity, ensuring quality and compliance.
Responsibilities:
- CAPA Management: Lead the strategic oversight and execution of Corrective and Preventive Actions (CAPA) to resolve product-related issues, ensuring timely and compliant closure of CAPAs.
- Regulatory Compliance: Ensure all product care activities adhere to regulatory guidelines, including IVDR and ISO13485, maintaining up-to-date product documentation and compliance records.
- Cross-Functional Collaboration: Foster positive relationships with R&D, Production Planning, Marketing, and QA/RA for smooth operational flow.
- Continuous Improvement: Championing continuous improvement initiatives to improve product quality and performance, applying root cause analysis to prevent recurrence of issues.
- Audit and Documentation Management: Lead defense in audits, internally and externally; manage creation and upkeep of product care docs for regulatory compliance.
- Team Leadership: Lead and develop a scientific team dedicated to product care activities, promoting professional growth and ensuring efficient and effective task completion.
Minimum Requirements/Qualifications:
- Master’s degree or equivalent experience in Biology, Immunology, or a related scientific field, preferably with additional qualifications or certifications relevant to the IVD industry.
- Profound experience in assay or medical device development, with a proven track record in managing product life cycles and compliance in a highly regulated environment.
- Strong leadership and problem-solving skills, excellent organizational abilities, and proficiency in managing complex projects and initiatives.
- Outstanding communication skills with proficiency in English, both written and spoken, necessary for effective collaboration across diverse teams and collaborators. German is a plus.
What we offer:
- Employment with a forward-thinking organization
- 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 outstanding minds has an outstanding 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.
Apply today! http://jobs.thermofisher.com
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