Sr. Manager Quality Compliance

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.