JOB SUMMARY

The Supplier Quality Auditor is a key member of the global Supplier Quality organization within the Pharma Services Group at Thermo Fisher!
By joining the global supplier management team, you will receive benefits of individual development, challenge career path for growth, ideal balance between life and work, and what more, an excellent team to work with!
We, as global supplier auditors, are responsible for global supplier Management including supplier auditing, supplier qualification. We aim to be an outstanding supplier management team that provides a continuously improving, controlled, compliant and effective program through the recruitment and sustainment of competent talents.
The person can be located in France or in Germany remotely.

EDUCATION

• Bachelor’s of Science Degree or related field, or a combination of education and experience.

EXPERIENCE

• A minimum of 10 years experience in pharmaceutical or medical device industry, or highly regulated industry with at least 5 years in Supplier Quality Management and auditing
• Epertise in regulations and standards such as cGMP, ICH Q7A, ISO, CFR 21, EudraLex, etc.
• Quality auditor certification preferred.
• Experience in data management, collection, analysis and technical writing

KNOWLEDGE, SKILLS, ABILITIES

• Position requires travel 50%+and requires flexibility at times for urgent needs.
• Proficient in the development and execution of quality management systems.
• Project planning and understanding of Excel, Word, Access, and supplier quality management software (i.e. SAP, TrackWise, etc.).
• Excellent social skills: ability to build relations and partner with internal and external customers.
• Strong communication skills in written and spoken English.
• Ability to maintain a high level of accuracy and attention to detail.
• Ability to work independently and in team, possess problem solving ability.
• Appreciates and respects diversity & Inclusion, Multi-cultures and values.

ABOUT US

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, protected veteran status, disability or any other legally protected status

• Perform assigned audits according to a risk-based supplier auditing program for all external suppliers within PSG division.
• Responsible and lead the supplier audit process, ensure adequate preparation, timely report issuance, observation and audit closure. Manage audit refusal and audit postponements.
• Monitor personal metrics and progress towards global goals
• Work with external suppliers for the CAPA implementation, risk assessment and drive continuous improvement and implementation of regulatory requirements to ensure supply chain sustainability.
• Supervise the supplier qualification status for the assigned PSG site, ensure supplier qualification criteria are met, maintain and update approved supplier list.
• Contribute to global team project activities and support process continuous improvement projects
• Act as the liaison between GSQ and assigned PSG manufacturing sites, maintain routine interaction, and provide support to for all supplier quality related issues.
• Act as SME and key contact with cross functions (project, supply chain) for all supplier quality related issues.