When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world.
- Maintain awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation.
- Stay abreast of all upcoming changes to Product Safety and Compliance regulations and standards to ensure the organization is meeting all current requirements for new and legacy products.
- Assess product regulations and standards impact to meet global requirements
- Provide leadership to sites to ensure global product compliance requirements are understood.
- Advise Divisional and BU leadership teams regarding strategies related to new and changing regulations and standards, including assessment of business compliance risk
- Work closely with new product introduction teams to meet compliance requirements on schedule
- Ensure all necessary compliance documentation is current and available upon request.
- Oversee the operations of the design compliance group to ensure accurate results, adherence to Company protocols, and timely completion of projects.
- Interface with corporate partners regarding quality issues, audits, and special projects.
- Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.
- Prepare and/or review documentation required for regulatory submissions.
- Maintain metrics for the QC function and continuously improve the area in terms of quality, efficiency and effectiveness.
- Actively lead initiatives toward continuous development, training, mentoring and/or coaching of staff in the Quality Control organization.
- Lead the group of approximately 20 people to meet corporate goals.
- This position is responsible for other duties as assigned.
- Bachelor’s degree in a Technical or Engineering discipline required.
- Experience implementing Design for Compliance and training programs.
- Experience with Lab/ IVD/ Medical equipment is preferred.
- Excellent interpersonal and communication skills with ability to effective interface with technical personnel at various levels of the organization.
- Ten (or more) years of progressive professional experience, with a minimum of 5 years in management within pharmaceutical Quality Control.
- Strong knowledge of regulatory guidelines and their application.
- Excellent written and verbal communication skills.
- Ability to act quickly and decisively.
At Thermo Fisher Scientific, each one of our 50,000 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
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.