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? 
This position will provide leadership and program management support for the product proactive Quality. The manager will perform duties to ensure project requirements are established and completed within a defined timeframe determined by internal customers such as Operations, PDS, and QA/QC. The purpose of this role is to identify product and process risks; to outline improvement opportunities to mitigate identified risks; create a structure to maintain design decisions and learnings for future use. This position will manage the Proactive Quality team.

What will you do?

• Manage the APR/CPV team.
• Manage Site Data Integrity program
• Manage Site Regulatory and Change Control program
• Manage and coordinate various workstreams within the Proactive Quality program, involving projects across the site.
• Drive the development of prioritized evaluation, planning and implementation approaches for products/projects that may be candidates for the proactive quality initiative.
• Review and challenge where necessary the associated project plans from a technical quality and risk management point of view.
• Devise milestones for the proactive quality process; create a review process to assess the outcomes of the proactive quality analysis.
• Provide recommendation action plans for improved solutions to common challenges.
• Develop and co-ordinate scorecard/metrics for measurement of the program.
• Lead communication of the program to corporate Risk Management COP team and Senior Management.

DELIVERABLES/METRICS:

• Products placed into a CPV program and reports sent to customers on committed timing
• Product and process risk assessments.
• APR reports completed on-time
• Data Integrity plan completed on-time
• SOP simplification when done through kaizen with users.
• Batch record simplification when done through kaizen with users.
• Project post-mortems performed
• Implemented CAPAs that have an effectiveness check
• Implementing and then checking effectiveness of corporate standards

• BS degree Required. 
• 15+ years regulated QA experience
• People Management Experience Required.
• Experience leading large organizations.
• Experience with regulatory agencies, compliance & auditing.
• Manufacturing experience, CDMO is a plus.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com