Sr. Regulatory Compliance Associate
Requisition ID: 73858BR
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 Sr. Regulatory Compliance Associate is responsible for site inspection readiness, conducting internal audits of Quality systems, facilitation of client audits, and facilitation of Critical Change Control process. This individual ensures compliance with FDA, EMA and other cGMP regulations, including client requirements.
What will you do?
- Maintain and participate in site inspection readiness program
- Lead preparation, execution and follow up activities related to regulatory inspections, including routine GMP and Pre-Approval inspections. Serve as site host for regulatory inspections.
- Lead site internal audits, including planning, execution, report writing, response approval and follow through of remediation activities. Train and mentor junior auditors.
- 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.
- Conduct compliance walkthroughs of all GMP areas on a routine basis.
- Lead continuous improvement projects for department.
- Own Change Control (CC) System as required, including driving/implementing improvements to system, monitoring health of system through appropriate metrics, and adjusting metrics as needed.
- Review and approve system related events or deviations and CAPAs
- Prepare and facilitate Site Management Review as needed
- 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 7 years of experience in a Quality role in a cGMP environment required
- At least 2 years of experience in conducting internal audits of Quality Systems required.
- Previous experience with writing and/or approving deviations is required.
- Previous experience with GMP Change Management Quality System is required.
- Previous experience with metric compilation and reporting is preferred.
- 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.
Associated topics: attorney, business, company, compliance office, counsel, court, lawyer, legal, legal affairs, llp