Pharmacy FDA​/503B Compliance Manager

Pharmacy FDA/503B Compliance Manager Dallas, TX 75226 | $95,000–$105,000/year | Full-Time

About the Role We are seeking a Compliance Manager to support day-to-day operations within the organization's Quality Management System (QMS). This role will help ensure that pharmaceutical manufacturing, laboratory, and distribution activities comply with FDA Current Good Manufacturing Practices (cGMP), applicable state board requirements, USP standards, and internal quality standards. The Compliance Manager will play a key role in document control, deviation and investigation support, CAPA management, internal auditing, batch record review, and regulatory inspection readiness.

Experience in pharmaceutical manufacturing, 503B outsourcing facilities, specialty pharmacy, compounding, or another FDA-regulated environment is strongly preferred.

• Coordinate the review, revision, approval, and issuance of Standard Operating Procedures (SOPs) and master batch records.
• Maintain controlled quality documentation within the QMS.
• Assist with investigations involving manufacturing deviations, non-conformances, and Out-of-Specification (OOS) laboratory results.
• Support root cause analysis and ensure investigation documentation is complete and accurate.
• Monitor 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.
• Review and audit executed batch records, logbooks, sterilization records, and related manufacturing documentation.
• Verify documentation accuracy, completeness, and data integrity prior to product release.
• Support ongoing audit and regulatory inspection readiness.
• Collaborate with Manufacturing, Quality, Laboratory, Pharmacy, and other cross-functional teams.
• Identify opportunities for continuous improvement within the QMS.

• Utilize compliance monitoring and risk assessment techniques to identify and mitigate regulatory risks.
• Support the development and continuous improvement of compliance programs and internal controls.
• Conduct or support internal audits and compliance assessments.
• Lead or support internal investigations, including root cause analysis and documentation of findings.
• Track CAPAs and other quality actions through timely resolution.
• Prepare compliance reports and documentation for management review and regulatory readiness.
• Provide compliance-related training and guidance to employees.
• Monitor changes to applicable regulations and industry standards and assess organizational impact.
• Apply risk management principles to support proactive compliance strategies.
• Promote a culture of quality, integrity, accountability, and regulatory compliance.
• Support inspections conducted by the FDA, state regulatory agencies, and external auditors.

• Bachelor's degree in Chemistry, Microbiology, Biology, Pharmacy, or another relevant scientific discipline.
• 2–4 years of experience in QA, QC, compliance, or quality systems within an FDA-regulated pharmaceutical or similar industry.
• Working knowledge of FDA cGMP regulations, including 21 CFR Parts 210 and 211.
• Familiarity with USP and requirements.
• Experience working with an electronic Quality Management System (eQMS).
• Proficiency with Microsoft Office or comparable business software.
• Strong understanding of quality documentation, investigations, CAPAs, deviations, and audit processes.
• Strong written and verbal communication skills.
• Ability to collaborate effectively with cross-functional teams.

• Pharmaceutical manufacturing experience.
• 503B outsourcing facility experience.
• Experience in a compounding pharmacy or specialty pharmacy environment.
• Experience with cleanroom monitoring or aseptic processing compliance.
• Experience with batch record review and pharmaceutical manufacturing documentation.
• Experience supporting FDA or state regulatory inspections.
• ASQ Certified Quality Auditor (CQA) or similar quality/compliance certification.
• Experience with risk assessments, root cause analysis, and continuous improvement initiatives.

The ideal candidate is a…