Single Use Technology Audit Lead, Quality Systems

Work Schedule

Standard (Mon-Fri)

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions.

Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Join the Single Use Technology, Quality Management System team, at Thermo Fisher Scientific Inc., where you will work in a dynamic and collaborative environment. This is an onsite position in Logan Utah, Millersburg , Pennsylvania, Nashville, TN or Cramlington, UK. Residency near either locations is required. No relocation assistance provided.

Lead audits, drive improvement, ensure compliance with quality and regulatory standards as the Single Use Technology Audit Lead.

• Develop and maintain the annual network internal audit schedule
• Conduct internal audits and collaborate effectively with cross-functional teams
• Lead the network external audit program, ensuring risks are identified and communicated across the business
• Assist Customers with quality management system queries
• Manage the network desktop audit package to ensure it remains up to date.
• Maintain external audit procedures and associated documentation.
• Generate and manage metrics to monitor audit performance across the network.
• Support the Customer Quality Agreement process
• Apply Practical Process Improvement (PPI) to drive continuous improvement in the audit process.

• Bachelor’s Degree in a scientific field or proven experience within Biotech/Pharma quality management systems

• Minimum of 2 years in a Quality Management System role
• Successfully delivering large and complex improvement initiatives
• Certified as a Lead ISO 13485 auditor.
• Expertise in GMP standards

• Proven ability to participate in groups, manage deliverables and establish relationships
• Excellent written and oral communication skills: ability to communicate effectively with customers and compose and deliver outstanding presentations.
• Outstanding interpersonal skills, including collaboration and negotiation
• Experience in developing and managing project plans and priorities.

This position may require approximately 25% travel, both domestic and international. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

#Start Your Story  at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Job Seekers with a Disability:
Thermo Fisher Scientific offers accessibility…