When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals
How Will You Make an Impact?
You’ll provide leaderships for our BioProduction Quality Network which includes 15 sites globally.We’re looking for someone who’ll contribute to the development and ongoing strategy of our Quality Management System.
What will you do?
- Develop, enhance, and sustain compliance systems for registered medical devices and pharmaceutical products while determining compliance to written standards (e.g. ISO) and ensuring consistent application of quality processes.
- Demonstrate strong leadership by coaching and mentoring team members and peers while providing Quality specific guidance across the organization.
- Make an impact by driving results and deploying key programs to ensure alignment of the organization to agreed goals.
- Collaborate and partner with the operations and commercial organizations to ensure customer fulfillment and participate in cross functional team projects.
- Drive resolution and proactive solutions to quality complaints and conduct advance data analyses to identify larger scale quality improvements.
- Manage matrix relationships to ensure compliance of the network across multiple product lines and communicate effectively to diverse audiences including senior leadership.
- Supports complex, cross-functional quality issues in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software).
- Ensures overall program and product quality improvement by guiding other team members in continuous process improvement, implementing preventative actions and reviewing lessons learned.
- Bachelor’s degree in Science or Engineering Disciplines.
- 10 years’ experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products.
- Proven experience with Lean and/or Six Sigma
- Support of Medical Device or Pharmaceutical New Product Introductions preferred
- Oversight procurement/suppliers from a Quality perspective preferred
- Expert knowledge of Quality Management System design and oversight from a Medical Device or Pharmaceutical perspective:
- Compliance with quality standards (e.g., 21 CFR Part 820, ISO 13485, 9001)
- Quality tools (e.g. FMEA, Risk Analysis, RCA)
- Global Systems (e.g. TrackWise, AGILE, E1/SAP, LIMS)
- Proficient in Computer applications and current software (Microsoft Excel, Outlook, Word, Access, Project).
- Exposure to Cell Culture/Microbiology preferred.
- Demonstrated ability in Quality Control methods and validations preferred.
- Strong Project management and PMP certification preferred.
- Regulatory Affairs Experience and/or RAPS Certification preferred.
- Multilingual capabilities preferred.
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