Job Description
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. As the world leader in serving science, with the largest investment in 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.
How will you make an impact:
- Lead the Life Sciences Group, Global Distribution Quality Assurance network in establishing and implementing the Quality Management System (including medical device/IVD regulatory requirements and applicable standards; 21CFR Part 820 QSR, ISO 13485:2016, MDR/IVDR as well as RUO products) supporting the global distribution of products that include strict cold chain management controls.
- Further establish and enhance all aspects of the Quality Management System from strategic planning to hands-on implementation on topics such as Distribution Quality Assurance/Control, auditing, document management, CAPA resolution, etc.
- Provide strategic Quality leadership in future business growth and in the integration of any new site transfers.
- Implement a "Problem Solving" culture to Quality issues that will drive sustainable Root Cause and Corrective Action.
- Innovate quality management processes to drive efficiencies in the distribution network through the application of artificial intelligence, machine learning, and other tools to support optimization of resources and minimize product supply disruption and unfavorable customer experiences.
- Ensure that the customer perspective is maintained as a priority in the work done every day.
How will you get here:
Education
Bachelor's Degree required, preferred in Engineering or Science
Experience
- Minimum of 10 years in a regulated medical device/pharma manufacturing company, including minimum of 5 years leading a quality organization responsible for QA/QC, CAPA, post-market surveillance and all facets of product quality and Production & Distribution controls.
- Demonstrate a working understanding of applicable global medical device regulations and standards, (21 CFR Part 820, ISO13485, EU 2017/745 MDR, risk management ISO14971, and other relevant global standards), design control principles.
- Champions Quality by Design through the application of Production & Distribution controls, statistical process control, practical process improvement and other tools which support QMS compliance and advancement.
- Knowledge of Production & Process controls or Distribution controls. Handling distribution issues impacting licensed medical devices, IVDs, chemicals, controlled substances
- Shipping qualification processes including packaging, cold chain management
- Knowledge of Risk Managing tools including application of these tools.
- Financial acumen including AOP planning
Knowledge, Skills, Abilities
- Strong authentic people leadership skills.
- Strong Continuous improvement and Problem-solving experience (Lean approach)
- Outstanding communication skills with an ability to influence on a global level.
- Managerial courage and decisiveness
- Adaptable when priorities change
- Experience in distribution and transportation preferred
Our Mission is to enable our customers to make the world healthier, cleaner and safer. 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.
