Compliance Manager – Pharmaceutical Quality & Compliance

Position Overview
We are seeking a Compliance Manager to support day-to-day operations within a pharmaceutical Quality Management System (QMS). This position will help ensure manufacturing, laboratory, and distribution activities comply with FDA Current Good Manufacturing Practices (cGMP), applicable state requirements, USP standards, and internal quality policies.

The ideal candidate will have hands-on experience in pharmaceutical QA/QC or compliance, with a strong understanding of cGMP requirements, investigations, CAPA, document control, audits, and batch record review. This is an excellent opportunity for a quality professional who wants to take an active role in maintaining regulatory compliance and audit readiness.

Key Responsibilities

• Coordinate the review, revision, approval, and issuance of Standard Operating Procedures (SOPs) and master batch records.
• Support investigations involving manufacturing deviations, non-conformances, and Out-of-Specification (OOS) laboratory results.
• Monitor and coordinate Corrective and Preventive Actions (CAPAs) and change controls to ensure timely completion and closure.
• Participate in internal facility inspections and quality audits to identify compliance gaps and ensure adherence to cGMP requirements.
• Review executed batch records, logbooks, and sterilization records for accuracy, completeness, and data integrity prior to product release.
• Utilize compliance monitoring and risk assessment techniques to identify and mitigate potential regulatory risks.
• Support the development, implementation, and continuous improvement of compliance programs and internal controls.
• Conduct and support internal audits and compliance assessments.
• Lead or support investigations, including root cause analysis, documentation, and follow-up actions.
• Prepare compliance reports and documentation for management review and regulatory readiness.
• Provide compliance-related training and guidance to employees across departments.
• Collaborate with manufacturing, laboratory, pharmacy, and other cross-functional teams to promote a strong culture of quality and compliance.
• Monitor changes to applicable regulations and industry standards and evaluate their potential impact on operations.
• Apply risk management principles to support proactive compliance strategies and continuous improvement.
• Maintain ongoing audit readiness and support regulatory inspections and external audits.