Quality Performance and Compliance Leader

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.

Location/Division Specific Information

Our facility is in Mount Prospect, IL, just 20 minutes from O’Hare airport. This facility is part of the Clinical Trials Division; our mission is supporting our clients on the forefront of modern medicine.

How will you make an impact?

This role directly supports the packaging of investigational new medicines or medical devices intended to treat diseases / illnesses. These investigational products are for use in clinical studies and are not available by prescription in commercial pharmacies. In this role, you are responsible for ensuring that company Quality policies and procedures are followed throughout the process and a GMP compliant product is shipped out.

What will you do?

• Lead, Facilitate, and Participate in Quality related investigations and process improvements with various departments (i.e. performing analysis, investigation of adverse quality trends, implementation of Global Improvement Projects, etc.).
• Assures site’s process and Quality Systems are in compliance with all applicable government regulations and FCS Standard Operating Procedures, CTD Global Policies and Procedures, and meet Customer requirements.
• Collect and provide Quality Data for generating, tracking, trending, and reporting Quality Metrics.
• Lead and facilitate local Quality Council meetings and Management Reviews with site Leadership, participate in Quality Business Reviews (QBRs), and track action items to completion.

How will you get here?
Education

• Bachelor’s degree (B.A./B.S.) from a four-year college or university in Life Sciences (Molecular Biology, Biochemistry, Chemistry) or related field; or equivalent experience

Experience

• At least five years of experience as a QA/QC/Compliance Professional in a pharmaceutical environment or related field
• At least two years of experience using QA Investigational Software (preferably Trackwise).

Knowledge, Skills, Abilities

• Must possess the solid ability and experience in effectively leading Quality Investigations (define problems, collect data, establish facts, and draw valid conclusions) and facilitating cross-functional teams in performing investigations and root cause analysis, leading to the identification of appropriate corrective and preventative actions.
• Working knowledge of Process Improvement, Quality Management, and/or other process improvement tools i.e. Six Sigma, Five Why’s. Value Stream Mapping, Fish bone, 4 M’s and E.
• Must have the ability to write reports, business correspondence, and procedure manuals. Must also can effectively present concise information and respond to questions from Senior Management, peers and clients.
• Ability to effectively interact with a diverse range of individuals including external clients and operate and/or project a strong professional image.

At Thermo Fisher Scientific, each one of our 75,000 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.