Job Summary:
Act as an independent reviewer and evaluator to ensure that Quality Compliance issues/concerns within the organization are appropriately evaluated, investigated, and resolved. Performs cGMP audits of manufacturing units, contract manufacturers, contract packagers, and vendors for regulatory agency review (i.e., FDA, DEA, etc.) on a need basis. Ensures that all Avet Laboratories, Avet Pharmaceuticals, Inc., and Avet Life Sciences sites are continually in a state of cGMP inspection readiness by driving compliance with all applicable cGMP Regulations and has ownership for cGMP Compliance Training.
The role requires the incumbent to physically be onsite Monday – Friday.
Reporting Relationships
Individual contributor. However, depending on the need, the role can also be converted to a supervisory role.
Essential Functions:
- Responsible for developing, implementing, and overseeing the organization’s compliance program.
- Monitor changes in regulatory requirements and implement necessary updates to the compliance program.
- Oversee the maintenance and effectiveness of the implemented system/procedures in Operation and Quality functions.
- Ensuring continuous improvement in the Quality systems and practices in line with cGMP regulations/Regulatory expectations.
- Identify and mitigate the compliance risk associated with the different functional areas/systems.
- Develop and deliver compliance training programs for employees at all levels.
- Interpret and ensure compliance with applicable regulations and guidelines and advise senior management on relevant business needs.
- Develop, implement, and maintain periodic (Quarterly) reviews of these systems and recommend corrective actions as appropriate.
- Actively participate in Quality Management Review.
- Develop, implement, and maintain a robust internal (Self-inspection) auditing program that aligns with cGMP expectations.
- Work in partnership with all departments (i.e., Research and Development, Engineering, Technical Services, Manufacturing, Quality Assurance, Quality Control, External Quality Supply and other applicable functions) to develop processes and procedures related to quality compliance for cGMP activities.
- Provide guidance and support to staff on compliance-related matters.
- Participate in and contribute to vendor development and qualification programs. Also, audit the vendors (raw materials, packing materials, contract testing laboratories, or other service providers) as per the in-house SOP to ensure that all vendors comply with cGMP standards.
- Investigate reports of alleged noncompliance and work with appropriate personnel, including HR, to ensure the proper and consistent application of any compliance-related disciplinary action.
- Maintain a database of all the relevant FDA 483 observations/ Warning Letters and use them as a training tool to inform and educate employees about the “Dos” and “Don’ts.”
- Apply the most current knowledge of managing regulatory inspections and following applicable regulations. This at times, requires making recommendations to change existing processes, equipment, and or systems, sometimes at considerable cost to the company or vendor partner.
Requirements:
- Bachelor of Science in Biology, Chemistry, Biochemistry, Pharmacy, or related field.
- A minimum of 8 years of experience in compliance oversight and auditing of all associated companies (providers, etc.) within the cGMP-regulated environment.
- Strong knowledge of cGLP and cGMP audits.
- Strong knowledge of domestic and international regulatory requirements related to cGMP-regulated manufacturing.
- Strong understanding of policies, guidelines, and systems related to Compliance/Quality programs.
- Experience in handling small to medium-sized teams.
- Experience in identifying and addressing issues efficiently and effectively.
- Experience with Federal DEA Regulations and practical industrial oversight experience for DEA-related activities.
- Knowledge of Microsoft Office – Word, Excel, and PowerPoint primarily.
- Knowledge of Trackwise software.
- Certifications like ASQ are a plus.
Key Competencies:
- Demonstrated ability to influence without authority.
- Effective and professional interpersonal skills.
- Effective problem-solving abilities to address and resolve compliance challenges.
- Strong verbal and written communication skills.
- Staff management and leadership skills.
Physical Demands/Factors:
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 essential functions.
Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required. The employee must frequently lift and/or move up to 5 pounds and occasionally lift and/or move up to 25 pounds.
Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.
All applicants must be legally authorized to work in the U.S. for any employer. We are unable to sponsor any applicants for a work visa or take over sponsorship of a work visa for any applicants, at this time.
All applicants will be expected to report to work at our New Jersey facility, however, in some limited cases, we may be willing to offer reimbursement of certain relocation expenses to an applicant based solely on the exercise of the Company’s discretion.
Avet is proud to be an Equal Opportunity Employer.
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.
