Regulatory Compliance Associate 3
Requisition ID: 72278BR
When you join us at Thermo Fisher Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location/Division Specific Information
St. Louis, MO
How will you make an impact?
The Regulatory Compliance Associate 3 is responsible for site inspection readiness, conducting internal audits of Quality systems and facilitation of client audits. This individual ensures compliance with FDA, EMA and other cGMP regulations, including client requirements.
What will you do?
- Active involvement in site inspection readiness program and execution of regulatory inspections, including routine GMP and Pre-Approval inspections.
- Lead site internal audits, including planning, execution, report writing, response approval and follow through of remediation activities.
- Facilitate all aspects of client audits, including planning, preparation, hosting, response development, and closeout activities.
- Provide interpretation and guidance to site personnel with respect to current regulations that apply directly or indirectly to approved drug products.
- Provide knowledge of current cGMP requirements and trends to ensure that the appropriate technical support on all quality/compliance related matters is provided to the site.
- Effectively communicate with peers, Manufacturing, Process Development, Quality Control and Program Management staff.
- Perform any other tasks as requested by Senior Management to support Quality and Regulatory oversight activities.
How will you get here?
- Bachelor s degree in a scientific discipline (Life Sciences, Biotechnology, or equivalent) is required.
- At least 5 years of experience in a Quality role in a cGMP environment required
- Previous experience in conducting internal audits of Quality Systems required.
- In-depth knowledge of FDA/EMA regulatory requirements required.
- Must be able to host client audits and regulatory inspections. Previous experience in these areas is highly preferred.
Knowledge, Skills, Abilities
- Proficient with computer (MS Office), and internet skills.
- Proficient in the use and understanding of controlled documentation and data systems.
- Demonstrated ability to excel in cross functional team environments.
- Well organized and detailed oriented.
- Excellent interpersonal, analytical/problem solving and communication skills.
- Ability to interact and collaborate with all levels of the organization.
- Ability to identify and facilitate change.
- Ability to give presentations to site leaders and clients.
At Thermo Fisher Scientific, each one of our 70,000 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.If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
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.
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