Job Description

At Microbial Material Services (MMS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, the expertise and resources necessary to help clients deliver innovative therapeutics. Placed in the forefront of our leading- and cutting-edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

How will you make an impact?

This position will play an important role in site’s Compliance team to ensure adherence and effectiveness of site’s self-inspections, timely delivery of our commitment to the customers and the patients.

What will you do?

• Manage site's self-inspection program including conducting Internal Audit and overseeing functional Walk-through to ensure adherence and effectiveness.
• Responsible for timely and effective execution of both internal and external audit commitments.
• Interact with SMEs in all functional areas of the site to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems.
• Analyze compliance performance trend and be able to identify and manage the metrics.
• Partner with Regulatory to assess new or revised regulations and standards. Be able to update current procedures, and provide guidance to functional areas.
• Part of site's audit team that hosts clients and regulatory audits.
• Assist the timely execution of assigned initiatives and activities under Audit Readiness program to identify and close site's compliance gaps, and ensure the site to be audit ready at all times.
• Manage projects assigned. Able to multi-task efficiently to ensure timely project completion.

This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.

How will you get here?

Education

• BS in Regulatory & Compliance, Biological Science or related technical field
• Minimal 5 years of experience in a Compliance or related Quality position supporting the manufacture and testing of pharmaceutical products in cGMP environment.

Experience

• Advanced knowledge of U.S. and EU regulations, related ICH guideline and industry standards.
• Experience performing audits, professional Auditor Certification preferred but not required.
• Proficient in an eDMS system and document formatting
• Demonstrated ability in managing tracking databases
• Skilled in use of Microsoft Outlook, Powerpoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures.
• This position requires the ability to work in a team environment to meet goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful. Individual must be self-motivated, have excellent quality and organization skills and be detail oriented.
• Strong interpersonal and communication skills and the ability to work effectively across all levels.

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.

Job Category

Legal & Compliance

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.