Location: Buena, NJ
- Serves as the company’s current Good Manufacturing Practices (cGMP) expert by keeping abreast of all current regulatory and statutory expectations and keeping the organization in a state of permanent inspection readiness.
- Serves as the primary audit leader and ensures compliance to all domestic and foreign regulatory and statutory requirements. This includes the code of federal regulations (CFR), the EudraLex, and all guidance documents that will be used to assess our compliance to industry standards.
- Ensures corporate policies are accurate, current and in compliance with all applicable regulations. Reviews and updates policies as the industry expectations change.
- Interprets and disseminates information on all compliance and regulatory matters.
- Vendor management and compliance.
- Collaborates with operational counterparts in order to train and mentor all company personnel in order to drive proactive improvements into the organization.
- Assesses all aspects of our Quality Management System through direct shop floor observations and audits. Identifies and remediates all observations through robust Corrective and Preventative Actions (CAPAs) and then determines the efficacy of these actions through periodic effectiveness checks.
- Interfaces with training to enhance our training program, which will be structured to address issues that illustrate positive trending.
- Assists with regulatory and compliance training.
- All other duties assigned by the department head.
- Familiarity with the salient portions of the Code of Federal Regulations and the EudraLex
- Experience with regulatory filings
- Quality operations and auditing background
- Communication Proficiency
- People Management
- Time Management
- Demonstrated Technical Capabilities
- Ethical Conduct
- Bachelor’s degree in biology, chemistry, physics, engineering or a related field or equivalent experience.
- A minimum of five years of compliance and/or regulatory experience.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.