Compliance Manager - Pharmaceutical Quality & Compliance 174209

Compliance Manager – Pharmaceutical Quality & Compliance

Location: Dallas, TX 75226
Salary: $95,000–$105,000 annually
Job Type: Full-Time
Work Setting: Onsite

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.

Required Qualifications

• Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmacy, or another relevant scientific discipline.
• 2–4 years of experience in QA, QC, compliance, or a related quality function within an FDA-regulated pharmaceutical or similar environment.
• Working knowledge of FDA cGMP regulations, particularly 21 CFR Parts 210 and 211.
• Knowledge of USP <797> and/or USP <800> requirements.
• Experience working with an electronic Quality Management System (eQMS).
• Experience with quality documentation, investigations, CAPA, change controls, and internal audits.
• Strong analytical, organizational, written, and verbal communication skills.
• Ability to work cross-functionally and communicate quality and compliance requirements effectively.

Preferred Qualifications

• Experience with cleanroom monitoring, sterile manufacturing, or aseptic processing compliance.
• Experience reviewing pharmaceutical batch records and sterilization documentation.
• ASQ Certified Quality Auditor (CQA) certification or similar quality/compliance certification.
• Experience supporting FDA or other regulatory inspections.

What We're Looking For

The strongest candidates will have a background in pharmaceutical quality assurance, quality control, or regulatory compliance and be comfortable working directly with cGMP documentation, investigations, CAPAs, audits, and batch records.

This role is particularly well suited for a quality professional with 2–4 years of hands-on pharmaceutical compliance experience who understands how quality requirements translate into day-to-day manufacturing and laboratory operations.

Salary: $95,000–$105,000 per year
Location: Dallas, TX 75226