Manager, Regulatory compliance
Business Job Title: Manager Regulatory Compliance
Internal Job Title: Sr Manager, Regulatory Affairs
Reports To: Director Quality Assurance
Group/Division: BioPharma Services Division
Career Band: 8
Job Track: Management
Position Location: Allentown, PA
Number of Direct Reports: Approximately 2
Day/Shift (if applicable): Day
FLSA Status (Exempt/Non-Exempt): Exempt
Relocation (if applicable): Yes, (as applicable)
When you're part of the team at Thermo Fisher, 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
- The Regulatory Compliance Manager is responsible for the management of the Compliance of the Allentown facilities to the US, EU, HealthCanda regulations. Provides oversight to and is directly responsible for the results of a team of compliance personnel.
- Support Regulatory agencies and Client Audits, assist with responses and trending of observations
- Member of the NA Audit Team, assist with supplier audits in support of FCS NA and other FCS sites as needed.
- Approve Customer compliance related correspondence
- Oversee the self inspection activities
- Maintain Regulatory Licenses (FDA, DEA,VAWD)
- Ensure regulatory compliance for the site in policies, procedures, and regulatory requirements
- Develop, maintain, and monitor regulatory/compliance SOP's.
- Provide or assist on employee training to ensure compliance with procedures and regulations.
- Oversight of DEA activities
- Other duties and special projects may be assigned to meet business needs
- Bachelor degree (B.A./ B.S.) from a four-year college or university required.
- A minimum of 8 years of experience in the Pharmaceutical/Medical Device or Regulated industry with at least 5 years of direct management experience required.
- Experience with Quality Systems (audits, recalls, deviations, complaint management, documentation management, etc) in a pharmaceutical or applicable regulated environment.
- Familiarity with applicable CFR, cGMP, QSR, ISO, ICH and Health Canada standards/regulations.
- Effective communication skills to interact with employees in all departments of the organization including, but not limited to, managers, senior management, customers, vendors, and regulatory agencies.
- Travel is required to audit supplier locations and other FCS sites as necessary; overnight travel approximately 10%.
- May be required to travel domestically and internationally.
- Ability to manage multiple tasks and meet deadlines, work under pressure in a fast paced environment.
- Ability to walk and work in Operational area as required.
- Applies Good Manufacturing Principles in all areas of responsibility.
- Demonstrates and promotes the company vision.
- Ability to lift 10 to 20 pounds
- Support other related tasks as required.
·ASQ CQA or other comparable auditing association/body.
- Experience with Management, Six Sigma, Lean, Practical Process Improvement, etc.
At Thermo Fisher Scientific, each one of our 50,000 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. Apply today http://jobs.thermofisher.com
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.
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.