Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
How will you make an impact?
Lead quality initiatives at our Logan, UT campus and influence the development of Single Use Technology solutions to global Bio-Pharmaceutical and Biotech industry challenges. Ensure our products meet high standards and encourage a culture of quality throughout the organization.
What will you do?
Establish and implement the quality strategy for the Logan campus, ensuring compliance with applicable regulatory requirements, corporate policies, and customer agreements, and delivering a consistent supply of quality products across all shifts.
Serve as Management Representative of the QMS and primary contact for site leadership, customers, regulatory agencies and third party auditors for all quality and compliance matters at the site.
Establish, monitor, and take action to measure site performance against quality objectives and drive progress.
Act with intensity to cultivate collaboration with the Operations team, driving continuous improvement to effectivity and efficiency of quality systems processes, to deliver sustained compliance and safety, while reducing the Cost of Poor Quality to the business.
Optimize and implement supplier qualification and maintenance processes, and partner with suppliers to address supplier performance-related matters impacting factory performance.
Serve as a role model leader, aligning with the Thermo Fisher Code of Conduct and embodying our 4-i Values and Practical Process Improvement methodology in all actions.
Attract, retain and develop excellent talent to build a successful team, and encourage and educate all site employees to foster a culture of personal excellence, based on industry-leading practices and dedicated to improving the customer experience.
Support the commercial organization and lead Quality-related commercial discussions with customers.
Communicate and raise material claims and issues promptly in collaboration with Risk Management and Legal.
Perform all job duties in a safe manner, adhering to all safety policies and procedures.
How will you get here?
Education
Requires a bachelor's Degree in science or related engineering fields
Experience
10+ years of quality experience within the Medical Device or Pharmaceutical industries, supporting regulated products.
Minimum of 5 years in leadership/management in GxP compliance environments, preferably FDA regulated.
Proven track record with design controls and new product development.
Knowledge, Skills, Abilities
Ability to think critically to overcome business hurdles and demonstrate history of achieving results with a proactive and problem-solving approach.
Shown success in attracting, recruiting, developing, and retaining high-potential talent and working with a diverse group in a matrixed environment.
Build strong credibility and cultivate positive professional relationships with subordinates, peers, leaders, and external collaborators.
Excellent written and verbal communication skills.
