What are the responsibilities and job description for the Director of Quality Regulatory position at The Assurance Group?
Director of Quality Regulatory is needed for busy manufacturer located in the Morris County, NJ area. The Director will review and update the company's SOP’s with other departments in order to keep the procedures up to date based on the FDA regulations. As a team member of the Regulatory & Compliance Department, you will be the lead contact for Government, third party and customer audits.
Additional responsibilities:
· Yearly registrations – FDA, NJ License/Permit, Health Canada, FSRN etc.
· OTC Product Registrations NDC’s
· Annual OTC reporting
· Accelerated Drug Stability submissions, review and reporting monthly results to customers
· Review and approve all protocols and reports for validations, IQOQ’s
· Review and approve all Deviations and Change Controls for all departments (review and approve all Master Batch Records against the R&D formula or customer transfers and all changes)
· Oversee the employee SOP training program and conduct training
· Review and approve Annual Product reviews
· Participate in line trials, OTC validations and new launches
· Participate in weekly meetings with customers
The Director of Quality Regulatory must have a solid background in regulatory and compliance. SOP, FDA, and personal care / cosmetics experience. Team leader with great attention to detail skills.
To discuss in greater detail, please send resume outlining your regulatory and compliance experience.
About the Assurance group
Securing top talent for our clients has been a passion for our each of our recruiters who have been representing the Assurance group for over 20 years. We work with some of the best companies in every industry….they are essential, entrepreneurial and enthusiastic about the future. Our tenure has given us the tremendous advantage to maintain relationships with both our clients and candidates
#IND2
Job Type: Full-time
Pay: $90,000.00 - $95,000.00 per year
Benefits:
- 401(k)
- Health insurance
- Paid time off
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Wharton, NJ: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person
Salary : $90,000 - $95,000
