Sr. Manager Regulatory Affairs and 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.

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?

• Owns and oversees all activities and performance of individuals in the following quality functional areas: all Regulatory & Compliance activities, quality Document Control, internal and external Audits and associated responses, and the Investigation process (immediate and permanent solutions identified, implemented & validated; with every step properly documented).
• Assures site’s processes are following all applicable government regulations, and FCS Standard Operating Procedures and meet Customer requirements.
• Lead 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.).
• Provide oversight to the site Qualification and Validation activities in accordance with applicable Quality/Regulatory requirements and industry best practices.
• Directs, monitors, and effectively appraises the performance of all direct reports; recommending or providing training and development activities where appropriate, including overseeing overall development strategy for each direct report.

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.

Experience

• At least eight years of experience as a QA/QC/Compliance Professional in a pharmaceutical environment or related field.
• Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, Process and equipment validation among others).
• Experience in regulatory audits, ISO certification, GMP requirements.
• At least five years’ experience in people management, mentoring junior staff and good conflict management skills.

Knowledge, Skills, Abilities

• Experience with Quality Systems (Change Control, deviations, complaint management, documentation management, Process and equipment validation among others).
• Experience in regulatory audits, ISO certification, GMP requirements.
• Must have strong project management, statistical analysis, and communication skills.
• Must have good working knowledge of cGMP Regulations.
• Proficient in use of Microsoft Office Suite and working knowledge of Document Control System such as (Documentum), Investigation Management System such as (Trackwise), and Learning Management System such as (Success Factor).
• Organizational skills are required in order to quickly retrieve needed documents.

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.