Director, Quality and Regulatory

Job Description

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.

Position Summary:

The Director, Quality and Regulatory will oversee the High-Performance Chromatography Solutions (HPCS) and Software Business Unit quality system and quality assurance strategies. Reporting to the Vice President of Chromatography & Mass Spectrometry Division (CMD) QARA, this position will be responsible for ensuring the highest level of quality and compliance in our operations, products, and services. Your expertise and leadership will be instrumental in driving continuous improvement, implementing quality management systems, and ensuring regulatory compliance in a rapidly evolving industry. This role will provide leadership by ensuring strategic quality planning, regulation monitoring, and QMS integration/improvement activities are effectively established and maintained according to business needs.

Key Responsibilities:

• Build and drive a Quality vision and strategic objectives that aligns with our High-Performance Chromatography Solutions BU.
• Lead and inspire a strong global quality team by hiring and developing strong quality leaders, establishing and actively managing performance expectations, and providing development and training opportunities.
• Drive operational excellence by effectively using continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Product Quality, reduce costs of poor quality, and align with strategic objectives.
• Establish network wide QA priorities and key objectives to improve the compliance to regulations and the global Quality Management System.
• Ensure global QMS training is effective and operate within the required regulatory guidelines.
• Uphold awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation
• Assess product regulations and standards and the impact to meet global requirement
• Collaborate with corporate & divisional partners regarding quality issues, audits, and special projects
• Influence and build strong working relationships across organizations and geographies and engage with business partners to define existing gaps and future requirements for Quality Management Systems.
• Ensure effective management of the global Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, NPDI.
• Drive the continuous improvement of Quality Management Systems, including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, and NPDI process support.
• Support the commercialization of New Product Introductions by working with cross functional NPDI team members.
• Collaborate with Regulatory organization to ensure compliance to applicable regulations.
• Lead executive quality management reviews.
• Other miscellaneous duties as assigned.

Minimum Requirements/Qualifications:

• Bachelors degree in a relevant scientific or engineering field; advanced degree preferred.
• Extensive experience (at least 5-10 years) in quality management preferably within the Life Sciences, Pharmaceutical Industry or software industry.

• Customer focus – Puts the customer at the front of every decision, including work prioritization, resource investment, and process improvement
• Quality systems – Ability to practically implement strong quality systems that provide the necessary controls as defined by regulatory, marketplace and our customers.
• Building a team – Builds a strong team and has a strong capability to marry strategy, organizational structure, and capable leaders
• Operational execution – Clear view of the mechanisms necessary to manage a quality assurance organization efficiently and effectively
• Ability to demonstrate flexibility and manage multiple complex projects simultaneously
• Ability to manage from and across remote locations
• Ability to travel up to 30%

At Thermo Fisher Scientific, each one of our 100,000 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!!

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.