Quality Systems Manager

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll engage in impactful work, innovative thinking, and a culture dedicated to doing things the right way, for the right reasons—with the customer always top of mind. Our work matters, whether it's helping customers find cures for cancer, protecting the environment, ensuring food safety, or delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential within a fast-growing, global organization that values passion and unique contributions. We are committed to providing our colleagues with the resources and opportunities they need to make a difference in our world while building fulfilling careers.

**Discover Impactful Work:**

As part of the Quality Systems Team, you will implement and manage processes crucial for the quality of our products, meeting the high expectations of our customers in Pharmaceutical Development. You will achieve this by collaborating closely with other functions and departments to identify solutions for diverse challenges and independently striving for continual improvement of Quality Management System processes.

**A Day in the Life:**

- Review and discuss proposed changes with process experts to assess these changes from a quality perspective.
- Supervise and improve document management and the training system to ensure functionality and consistency.
- Perform internal audits and follow up on resulting observations and opportunities for improvement.
- Support other departments and functions regarding Quality Management to ensure consistent product quality and continual improvement.
- Maintain the Quality Systems in compliance with Current Good Manufacturing Practices (cGMPs), global regulatory requirements, company policies, procedures, and all other applicable regulations and guidelines. Focus on leading the Change Control program, Deviations, Controlled Substances Program, Vendors Program, Complaints, Deviations, SOPs, Annual Product Review, and Audits.

**Keys to Success:**

**Education:**

- B.Sc., M.Sc., or PhD in Natural Sciences or Engineering.
- Further qualifications in Quality Management or Quality Assurance encouraged.

**Experience:**

- Advanced knowledge of Quality Management Systems with at least 2 years of experience.
- Expertise in lead/supervision and managerial roles with demonstrated ability and at least 5 years of experience.
- Knowledge of fundamentals and processes of Quality Assurance for Pharmaceuticals (cGMP) encouraged.
- Basic expertise in Oral Solid Dosages and associated techniques advantageous.

**Knowledge, Skills, Abilities:**

- Structured and diligent working style, coordinate yourself independently.
- Strong interpersonal skills to work as a member of a team and collaborate optimally with other teams and functions.
- Expertise in Quality Analytical skills and the ability to use critical judgment.
- cGMP and FDA compliance knowledge.
- Interpersonal and communication skills (both oral and written), leadership ability, and organizational skills.
- Possesses a quality, regulatory, and production mentality, including an appreciation for client service and contract manufacturing.