Director, Global Quality & Compliance
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 is a critical role on our leadership team which collaborates with a variety of global stakeholders across our matrixed organization. As the Director, Global Quality and Compliance you'll be responsible for evolving and driving compliance across our Life Sciences Group (LSG).
If you have the passion to be part of a world-class Quality team, join us and ensure the quality of products that improve the world of science and medicine.
What will you do?
- Provide leadership across several sites to ensure global product compliance requirements are understood.
- Counsel Divisional and Business Unit leadership teams regarding strategies related to new and changing regulations and standards, including assessment of business compliance risk.
- Lead the deployment and oversight of global Quality Management Systems. Manage a Key Opinion Leader (KOL) in QMS who drives QMS deployment and harmonization.
- Drive improvements in global validation programs. Manage a KOL in Validation who leads the creation of validation tools, provides consultancy support to execution of validation programs, and enables harmonization of validation principles across LSG and the broader Thermo Fisher Scientific organization.
- Uphold 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 and the impact to meet global requirements
- Collaborate with new product introduction teams to meet compliance requirements on schedule.
- Steer the operations of the global distribution quality group to ensure compliant warehousing, distribution, and logistics practices.
- Partner with the Global Field Service Engineering (FSE) organization to maintain oversight on all field activities. Direct a leader in quality responsible for oversight of the FSE organization.
- Provide matrix leadership and act as the KOL for the Design Compliance organization. Ensure accurate results, adherence to Company protocols, timely completion of projects, and the creation of Design History Files.
- Collaborate with corporate partners regarding quality issues, audits, and special projects.
- Guide Manufacturing with regard to quality and cGMP issues to ensure compliance with regulated standards.
- Prepare and/or review documentation required for regulatory submissions.
- Actively lead initiatives toward continuous development, training, mentoring and/or coaching of staff in the Quality Control organization.
- Inspire and lead a team to meet corporate goals.
How will you get there?
- Bachelor's degree in a Technical or Engineering discipline required.
- Experience implementing Design for Compliance and training programs.
- Experience in Cell Biology/Cell Therapy preferred.
- Experience with Lab/ IVD/ Medical equipment is preferred.
- Ten (or more) years of progressive professional experience, with a minimum of 5 years in management within pharmaceutical Quality Control.
- Communicates to effectively present to all levels of an organization internally and externally.
- Strong knowledge of regulatory guidelines and their application.
- Ability to act independently, quickly, and decisively.
- Capable to travel up to 50% (including international).
- Ability to work in a multinational/multicultural environment.
This position has been approved for relocation assistance.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
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.