Job Details

Regulatory Compliance Associates Inc. (RCA), A Nelson Labs company, provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges. Our recent acquisition by Sotera Health, a leading global provider of mission-critical sterilization, lab testing and advisory services further broadens our global presence within the life science industries.

Job Description:

RCA is seeking a Director of Quality to lead Quality Assurance (QA) and Quality Control (QC) for a leading 503B compounding pharmacy. This role is critical in ensuring compliance with USP <797>, USP <795>, USP <800>, and cGMP requirements. The ideal candidate will have extensive expertise in microbiology, sterile compounding, and aseptic processing, with a strong focus on contamination control, environmental monitoring, and sterility assurance programs.

Job Responsibilities:

Quality Leadership & Compliance

1. Develop and implement a comprehensive Quality Management System (QMS) ensuring full compliance with FDA, USP, DEA, and state board of pharmacy regulations.
2. Serve as the Quality Lead for regulatory inspections, audits, and compliance interactions.
3. Oversee QA/QC functions, including batch release, deviations, investigations, CAPAs, and change controls.
4. Ensure that all manufacturing processes meet sterility, potency, stability, and endotoxin testing requirements.
5. Lead internal audits, supplier/vendor qualifications, and third-party inspections to uphold regulatory excellence.

Microbiology & Sterility Assurance

1. Manage and enhance the Environmental Monitoring (EM) program, ensuring alignment with USP and cGMP standards.
2. Implement best practices for contamination control, aseptic techniques, and gowning procedures.
3. Collaborate with operations to improve cleanroom design, disinfection strategies, and airflow validation.
4. Conduct sterility risk assessments and oversee media fill programs and method validations.

Training and Continuous Improvement

1. Develop and implement comprehensive training programs for staff on sterile compounding, microbiology, and contamination control.
2. Foster a culture of quality and continuous improvement through risk-based decision-making and data-driven strategies.
3. Mentor and lead the Quality team, ensuring alignment with corporate quality objectives and regulatory expectations.

Qualifications:

1. Bachelor's, Master's, or Ph.D. in Microbiology, Pharmaceutical Sciences, or a related field.
2. 10+ years of experience in quality leadership roles within a 503B compounding pharmacy, pharmaceutical, or biologics manufacturing environment.
3. Strong expertise in microbiology, sterility assurance, and environmental monitoring.
4. In-depth knowledge of FDA regulations, USP <797>, <800>, <71>, <85>, and cGMP compliance.
5. Proven success in managing regulatory inspections (FDA, state boards, DEA) and audit processes.
6. Demonstrated ability to lead cross-functional teams and drive quality initiatives.
7. Experience with risk-based sterility assurance and contamination control strategies preferred.
8. Knowledge of sterile filtration, endotoxin control, and cleanroom classification requirements preferred.
9. Lean Six Sigma or other process improvement certifications are a plus.