Quality Assurance Manager (Pharmacy)

QA Manager - Contract - Kennett Square, PA

Proclinical is seeking a Quality Assurance Manager to oversee quality assurance, quality control, and compliance within a compounding pharmacy operation. This role focuses on ensuring adherence to USP standards (795, 797, 800), state pharmacy board regulations, and FDA expectations.

Primary Responsibilities:

The successful candidate will play a key role in maintaining and improving quality systems, training programs, and documentation standards to ensure the safe and compliant preparation of compounded medications.

Skills & Requirements:

• Bachelor's degree in pharmacy, Chemistry, Microbiology, or a related science (advanced degree preferred).
• Expertise in USP 795, 797, 800, and relevant state/federal regulations for 503A operations.
• Experience leading audits and managing regulatory inspections.
• Proficiency in quality systems (QMS), document control software, and data integrity principles (21 CFR Part 11 awareness preferred).
• Strong analytical and problem-solving skills, with experience implementing CAPAs and continuous improvement programs.
• Excellent communication and leadership abilities.
• Familiarity with environmental monitoring, media fill validations, and sterility assurance best practices.
• Prior experience in both 503A and 503B environments is a plus but not required.

The QA Manager's responsibilities will be:

Regulatory Compliance & Quality Systems:

• Ensure compliance with USP 795, 797, 800, state board regulations, and FDA guidance.
• Develop, implement, and maintain the Quality Management System (QMS), including SOPs, change control, deviations, CAPAs, and risk assessments.
• Prepare for and lead audits and inspections by state boards, FDA, and third parties.
• Monitor regulatory changes and update policies, procedures, and training accordingly.

Quality Assurance & Control:

• Oversee the release and approval of compounded products in line with internal quality standards.
• Lead batch record reviews, product testing, and resolution of quality-related issues or deviations.
• Ensure proper execution and review of environmental monitoring, cleanroom qualifications, and sterility assurance programs.
• Conduct routine observations of QA/QC activities, including aseptic techniques and environmental monitoring.
• Generate and review reports on quality trends, deviations, and key performance indicators (KPIs), escalating critical findings as needed.
• Lead investigations into non-conformances and implement effective CAPAs.

Leadership & Cross-Functional Collaboration:

• Manage and develop QA/QC personnel, fostering a culture of quality and accountability.
• Collaborate with pharmacy operations and compounding staff to address risks and maintain compliance with USP standards.
• Facilitate communication between production and QA/QC teams to uphold GMP discipline.

Training & Documentation:

• Develop and maintain USP-compliant training programs tailored to staff roles.
• Ensure training records, SOPs, logs, and controlled documents are accurate and audit ready.
• Support employee onboarding and ongoing education to reinforce best practices.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at [email protected]

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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