Position Summary
The Compliance Specialist will serve as a subject matter expert in sterile and nonsterile compounding practices, providing expert guidance on compliance with Federal and State regulatory requirements, including USP 795, 797, 800, and Section 503B of the Federal Food, Drug, and Cosmetic Act. This individual must possess a strong foundation in Current Good Manufacturing Practices (CGMP) and have practical experience in aseptic processing and/or quality assurance. The Compliance Specialist will lead and manage a variety of client-facing projects, including but not limited to compliance audits, gap assessments, SOP and process development, regulatory response and remediation planning, and aseptic technique training.
Essential Responsibilities
- Serve as a subject matter expert on Federal and State regulations governing sterile and nonsterile compounding.
- Conduct onsite and remote compliance audits and gap assessments, and generate detailed written reports with risk-ranked findings and remediation strategies.
- Develop customized regulatory remediation plans, including support for FDA Form 483 responses, Warning Letter resolutions, and State Board corrective actions.
- Draft, review, and revise Standard Operating Procedures (SOPs), master formulation records (MFRs), batch production records, and other documentation in accordance with regulatory requirements and industry best practices.
- Collaborate with clients to create process flows that optimize compounding operations.
- Lead and manage projects from initial screening and consultation to quotation, scheduling, resource coordination, deliverable execution, and submission of billing.
- Design and deliver training and education to support compounding personnel and leadership development.
- Act as a liaison between clients and internal technical teams to ensure project alignment, timely communication, and technical accuracy of deliverables.
- Support business development activities through technical expertise and represent the company at industry exhibits, conferences, and trade shows.
- Participate in speaking engagements, webinars, and educational forums as a recognized thought leader in sterile and nonsterile compounding compliance.
- Remain current on changes to compounding regulations, CGMP expectations, and industry trends.
- Contribute to internal knowledge-sharing efforts, including training junior staff and developing resource materials for exhibits and website.
Qualifications
- Degree in Pharmacy (PharmD, BPharm, or equivalent) from an accredited institution.
- Minimum of 5 years of practical experience in sterile compounding, including significant exposure to 503A and/or 503B operations.
- Strong working knowledge of USP 795, 797, 800, Section 503B of the Federal Food, Drug, and Cosmetic Act, and CGMP regulations (21 CFR Parts 210/211).
- Hands-on experience in aseptic processing, cleanroom behavior, and/or quality assurance in regulated compounding environments.
- Excellent interpersonal and written communication skills, with the ability to clearly convey technical information to clients and stakeholders.
- Ability and willingness to travel 25-50%, including site visits, conferences, and speaking engagements.
- Strong organizational skills and the ability to independently manage multiple client-facing projects across various timelines.
- Experience supporting or leading regulatory responses to FDA Form 483s, Warning Letters, or State Board of Pharmacy findings preferred.
