Compliance Manager

The Compliance Manager is responsible for supporting day-to-day operations within the Quality Management System (QMS). This role ensures that all manufacturing, laboratory, and distribution activities comply with FDA Current Good Manufacturing Practices (cGMP), state board rules, and internal corporate standards. The ideal candidate coordinates document control, assists with investigations and maintains audit readiness across the organization.

KEY RESPONSIBILITIES

Documentation Management: Coordinate the review, revision, and issuance of Standard Operating Procedures (SOPs) and master batch records. Deviation Support: Assist in investigating manufacturing deviations, non-conformances, and Out-of-Specification (OOS) laboratory results. CAPA Coordination: Monitor the progress of Corrective and Preventive Actions (CAPAs) and change controls to ensure timely closure. Internal Auditing: Participate in internal facility inspections to identify compliance gaps and verify adherence to cGMP. Batch Record Review: Audit executed batch records, logbooks, and sterilization records to ensure data integrity and completeness before product release.

REQUIRED SKILLS

Utilize compliance monitoring and risk assessment techniques to identify, evaluate, and mitigate potential regulatory risks. Support the development, implementation, and continuous improvement of compliance programs and internal controls. Conduct internal audits and compliance assessments to evaluate adherence to regulatory requirements, company policies, and quality standards. Lead or support internal investigations, including root cause analysis and documentation of findings. Track and facilitate corrective and preventive actions (CAPAs) to address identified compliance issues. Prepare clear, comprehensive reports and compliance documentation for management review and regulatory readiness. Deliver compliance-related training and guidance to employees across departments. Collaborate with cross-functional teams to promote a culture of quality, integrity, and regulatory compliance. Monitor changes in applicable regulations and industry standards and assess organizational impact. Apply risk management principles to support proactive compliance strategies and continuous improvement initiatives. Utilize strong written and verbal communication skills to engage stakeholders, present findings, and drive compliance awareness throughout the organization. Maintain audit readiness and support inspections conducted by regulatory agencies or external auditors.

REQUIRED EDUCATION

Bachelor's degree in Chemistry, Microbiology, Biology, Pharmacy, or a relevant scientific discipline.

WORK EXPERIENCE

2-4 years of experience working in a QA/QC or compliance role within an FDA regulated pharmaceutical or similar industry. Regulatory Knowledge: Solid understanding of cGMP regulations (21 CFR Parts 210/211) and/or USP compounding guidelines ( , ). Software Skills: Proficiency with standard electronic Quality Management Systems (eQMS) alongside standard office software.

PREFERRED EXPERIENCE

Experience with cleanroom monitoring or aseptic processing compliance. ASQ Certified Quality Auditor (CQA) or similar industry certification. #J-18808-Ljbffr Mark Cuban Cost Plus Drug Company, PBC