Compliance Manager (Dire Hire)
Direct Hire in DFW area
95-105K
I’m currently recruiting for a Direct Hire opportunity with my client for an experienced Compliance Manager to support day-to-day operations within the Quality Management System (QMS).
This is a great opportunity for a QA/QC or compliance professional with pharmaceutical or other FDA-regulated industry experience who is passionate about cGMP compliance, investigations, audit readiness, and continuous quality improvement.
Key Responsibilities
- Support daily operations within the Quality Management System (QMS)
- Coordinate review, revision, and issuance of SOPs and master batch records
- Assist with deviations, non-conformances, and OOS investigations
- Track and coordinate CAPAs and change controls through timely closure
- Participate in internal audits and facility inspections
- Review executed batch records, logbooks, and sterilization records for accuracy, completeness, and data integrity
- Support regulatory inspections and maintain audit readiness
- Conduct compliance assessments and identify potential regulatory risks
- Support root cause analysis, investigations, and corrective actions
- Develop compliance documentation and reports for management
- Provide compliance training and guidance across departments
- Monitor changes in applicable regulations and industry standards
Ideal Candidate
Bachelor’s degree in Chemistry, Microbiology, Biology, Pharmacy, or a related scientific discipline
2–4 years of QA/QC or compliance experience in an FDA-regulated pharmaceutical or similar environment
Strong knowledge of cGMP regulations, including 21 CFR Parts 210/211
Familiarity with USP <797> and <800> preferred
Experience with electronic Quality Management Systems (eQMS)
Strong investigation, documentation, and risk-assessment skills
Excellent written and verbal communication abilities
Experience maintaining regulatory and audit readiness
Preferred Experience
- Cleanroom monitoring or aseptic processing compliance
- ASQ Certified Quality Auditor (CQA) or similar certification
- Pharmaceutical manufacturing or sterile compounding experience
[email protected]
INDMN
Pay: $95,000.00 - $105,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
