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?

The QA Project Manager – Quality and Compliance Improvement role is responsible for leading small, medium, and large projects; and participating as a key contributor for large projects to correct quality and compliance problems; implement improvements in quality and compliance; and assure continued compliance with evolving quality and regulatory requirements.
What will you do?
 

• Understand requirements and processes for Best in Class Quality Management Systems and regulatory compliance
• Lead small. medium, and large cross functional and multi-site initiatives to identify, develop, modify, improve, and implement global process solutions for compliant Quality Systems.
• As a Project Manager, oversee all aspects of project scope, schedule, resources, risks and overall management to ensure and drive successful delivery.
• Ensure deliverables/milestones in project plans are achieved within cost, schedule, scope, quality and delivery 
• Assist in development of policies and procedures supporting Quality Systems and regulatory compliance
• Develop and deliver training content for Quality Systems processes and regulatory compliance
• Through the analysis of Quality and Compliance processes, and understanding of industry best practice, collect and translate Quality insights, ideas and concepts into clearly defined requirements for process improvements
• Demonstrate enthusiasm, take accountability and drive for results.
• Ensure that solutions implemented are scalable, flexible and consistent in all regions whenever possible.
• Coordinate with global counterparts to determine and communicate global impact of proposed changes.
• Participate in industry and other professional networks to ensure awareness of industry standards, trends and best practices in order to strengthen Quality Systems knowledge.

• Bachelors Degree in Engineering, Science, or related field

• Must have a minimum of 4 year’s experience in a Quality Systems role with experience in successfully leading large and complex improvement initiatives supporting Quality and regulatory compliance.
• Expertise in ISO 13485, IVDR, MDR, GMP requirements
• Experience in Operations a plus

• Strong expertise and practical experience with Project Management concepts and processes
• Ability to lead small, medium, and large cross functional and multi-site initiatives for the investigation and identification and retooling of process and systems solutions, and the development and deployment of these solutions to enable best in class Quality Systems and regulatory compliance. Projects may be multi-site and multifunctional in scope.
• Proven ability to lead groups, manage deliverables, and maintain client relationships
• Experience in developing and managing a project plan and priorities
• Demonstrates significant knowledge and work experience in relevant regulatory compliance and  Quality Systems functional areas, processes, and best practices, including IVDR and Medical Device regulations, CAPA management, Complaint Handling, Document Control, Change Control, QRB
• Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below; ability to prepare high quality presentations and deliver them effectively
• Ability to execute training needs analysis, prepare curriculum and deliver functional and advanced training.
• Ability to enable cultural transformations; act as a role model; and manage change
• Exceptional interpersonal skills, including teamwork, facilitation, and negotiation
• Ability to make decisions in the face of uncertainty and complex situations
• The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• This position may require approximately 25% travel. The travel may be both domestic and international.

 
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.