Senior Director of Quality
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?
Our commitment to quality is at the heart of our brand and is vital to our growth and success. This key role is responsible for working with the Leadership team to build a Quality vision that's aligned with the business strategy of our fast growing and evolving Genetics Sciences Division.
If you have the passion to be part of a world-class Quality team, join us and ensure the quality of products that improve the world of science and medicine.
What will you do?
- Build and drive a Quality vision and strategic objectives that aligns with our Genetic Sciences Division and Life Sciences Group operations.
- Lead and inspire a strong global quality team by hiring and developing strong quality leaders, establishing and actively managing performance expectations, and providing development and training opportunities.
- Coach and motivate a global Quality Assurance team with a mix of RUO (ISO 9001), HID, CE-IVD (13485), and GMP (21CFR820).
- Drive operational excellence by effectively using continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Quality service levels, reduce costs, and align with strategic objectives.
- Establish network wide QA/QC priorities and key objectives to reduce turnaround time, the cost of poor quality and improve the compliance to regulations and the site Quality Management System.
- Ensure global training is effective and that the plants operate within the required regulatory guidelines.
- Influence and build strong working relationships across organizations and geographies and engage with business partners to define existing gaps and future requirements for Quality Management Systems.
- Ensure effective management of the network / site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, process validation, internal auditing, R&D transfers, and manufacturing area support.
- Drive the continuous improvement of Quality Management Systems at sites around the world, including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, internal auditing, R&D transfers, validation, and manufacturing area support.
- Support the commercialization of New Product Introductions by working with Design Compliance team members.
- Collaborate with the Global Regulatory organization to ensure compliance to applicable regulations.
- Lead executive quality management reviews.
- Bachelor's degree in Science or Engineering Disciplines.
- A minimum of 10 years of Quality experience within the Medical Device, Pharmaceutical Industry or Clinical Testing industry.
- Decisive leader who's successfully managed larger teams in a highly matrixed organization.
- Demonstrated experience working with external customers and commercial teams creating strategies that address customer needs and product specification.
- Previous experience working global teams and applying global business acumen.
- Proven experience with Project Management and Lean Six Sigma methodology.
- Previous experience supporting Medical Device or Pharmaceutical New Product Introductions preferred.
Knowledge, Skills, Abilities
- Customer focus - Puts the customer at the front of every decision, including work prioritization, resource investment, and process improvement
- Quality systems - Ability to practically implement strong quality systems that provide only the necessary controls as defined by marketplace and our customers
- Transformation - Understand the levers necessary to elegantly transform a traditionally research based business to a mixed research and clinically focused business
- Building a team - Builds a strong team and has a strong capability marry strategy, organizational structure, and talented leaders
- Operational execution - Clear view of the mechanisms necessary to manage a global quality organization efficiently and effectively
- Ability to travel up to 50%
This position has been approved for relocation assistance.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
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.