Compliance Manager

Job Description

Job Description

About Company:

We started Mark Cuban Cost Plus Drug Company because every American should have access to safe, affordable medicines. If you don’t have insurance or have a high deductible plan, you know that even the most basic medications can cost a fortune. Many people are spending crazy amounts of money each month just to stay healthy. No American should have to suffer-or worse-because they can’t afford basic prescription medications.

About the Role:

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.

Minimum Qualifications:

• Education: Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmacy, or a relevant scientific discipline.

• 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 (<797> , <800>).
• Software Skills: Proficiency with standard electronic Quality Management Systems (eQMS) alongside standard office software.

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.

Preferred Qualifications:

• Experience with cleanroom monitoring or aseptic processing compliance.
• ASQ Certified Quality Auditor (CQA) or similar industry certification.

Skills:

The Compliance Manager utilizes compliance monitoring and risk assessment skills daily to identify and mitigate potential regulatory risks within the organization. Strong compliance management and internal auditing capabilities enable the manager to design effective controls and evaluate their performance through systematic audits. Internal investigations require analytical thinking and attention to detail to uncover root causes and ensure appropriate corrective actions are taken. Written and oral communication skills are essential for preparing comprehensive reports, delivering training sessions, and collaborating with stakeholders across departments. Risk management expertise supports proactive strategies that protect the organization’s integrity and promote a culture of ethical compliance.