Work Schedule
Standard (MonFri)
Environmental Conditions
Office
Job Description
Location / Division Specific Information :
Phadia GmbH in Freiburg is the German branch of Thermo Fisher Scientifics 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 toptier 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 postlaunch products for Autoimmunity ensuring quality and compliance.
Responsibilities :
- CAPA Management : Lead the strategic oversight and of Corrective and Preventive Actions (CAPA) to resolve productrelated issues ensuring timely and compliant closure of CAPAs.
- Regulatory Compliance : Ensure all product care activities adhere to regulatory guidelines including IVDR and ISO13485 maintaining uptodate product documentation and compliance records.
- CrossFunctional 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 :
Masters 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 problemsolving 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 forwardthinking organizationOutstanding career and development prospectsCompany pension scheme and other fringe benefitsExciting company culture which stands for integrity intensity involvement and innovationIf 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 100000 outstanding minds has an outstanding story to tell. Join us and contribute to our singular missionenabling 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!
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.
Required Experience :
Manager
Key Skills
Instrument,Lighting,Gym,Event Production,Beauty Therapy
Employment Type : Full-Time
Experience : years
Vacancy : 1