Head of cGMP Compliance, Director
Act as an independent reviewer and evaluator to ensure that Quality Compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved. Monitors and Performs cGMP audits of all manufacturing units, contract manufacturers, contract packagers and vendors for regulatory agency review (i.e., FDA, DEA, etc.). Ensures that all Avet Laboratories sites are continually in a state of cGMP inspection readiness by driving compliance of all applicable cGMP Regulations and has ownership for cGMP Compliance Training.
Individual contributor. However, depending on the need, the role can also be converted to a supervisory role.
- Always monitor and drive cGMP inspection readiness through ensuring cGMP compliance to regulatory requirements as well as any other statutory rules applicable in the development, manufacturing, and packaging of products.
- Develop, implement, and maintain quality compliance strategies to be in line with the business goals.
- Formulate quality compliance policies, guidelines, and systems to ensure that the quality of the company products, processes and procedures follow all applicable cGMP regulations.
- Interpret and ensure compliance to applicable regulations, guidelines, and advising senior management on relevant business needs.
- Develop, implement, and maintain periodic (Quarterly) reviews of these systems and recommend corrective actions as appropriate.
- Work in partnership with all departments (i.e., Research and Development, Engineering, Technical Services, Manufacturing as well as other applicable functions), to develop processes and procedures related to quality compliance for cGMP activities.
- Participate and contribute to vendor development and qualification program. Also audit the vendors (raw material, packing material, contract testing laboratories, or other service providers) as per in-house SOP to ensure that all the vendors are complying with cGMP standards.
- Develop, implement, and maintain a robust Internal (Self Inspection) auditing program in line with cGMP expectations.
- Coordinate regulatory, customer, vendor audits and to make sure that the all the audit observations are adequately addressed.
- Actively participate in Quality Management Review.
- Investigate reports of alleged noncompliance and working with appropriate personnel, including HR, ensure appropriate 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 of the “DO’s” and “Don’t”.
- Apply the most current knowledge of how to manage regulatory inspections and follow applicable regulations. This at times requires making recommendations to change existing processes, equipment and or systems, sometimes at considerable cost to company or vendor partner.
- Review and authorize (Approve/Reject) Quality System tasks on behalf and / or in the absence of Head QC and QA. With regard to cGMP compliance, the Vice President Quality and cGMP Compliance shall be responsible in absentia of the job holder.
- Applicant must hold a Bachelor of Science in Biology, Chemistry, Biochemistry, Pharmacy, or related field with Twelve (12) or more years of direct experience in a compliance and auditing role supporting a manufacturing organization within a 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 quality programs.
- Experience of handling small to medium sized team.
- Experience with Federal DEA Regulations and practical industrial oversight experience for DEA related activities.
- Knowledge of Microsoft Office – Word, Excel, and PowerPoint primarily
- Certifications like ASQ is a plus
Problem solving abilities through various investigative techniques
- Effective and professional interpersonal skills
- Strong verbal and written communication skills
- Staff management and leadership skills
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.
While performing the duties of this job, the employee is frequently required to travel via car, train, or plane, stand, sit, walk, see, hear; use hands and fingers regularly, handle, or feel objects, tools, or controls, and reach with hands and arms.
The employee must frequently lift and/or move up to 5 pounds and occasionally lift and/or move up to 40 pounds.
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.
At Avet, we require that all employees physically entering the workplace to be fully vaccinated against COVID-19, and you will be asked to present proof of vaccination before beginning employment unless you qualify for a reasonable accommodation based on a sincerely held religious belief or medical need.
Based on the highly regulated workplace at Avet, employees will be required to meet minimum English proficiency requirements.
|Job Category||Quality Control|