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The Pharmacy Quality Operations Manager is responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) supporting specialty pharmacy operations at the facility in Charlestown, Indiana. This role ensures inspection readiness, regulatory compliance, and effective execution of quality systems in alignment with NABP, ACHC, and URAC accreditation standards, applicable provisions of 21 CFR Part 211, and quality system principles aligned with 21 CFR Part 820.
This position owns site quality systems governance and operational quality controls and works in close collaboration with Operations Management.
Quality Management System - Establish and maintain a pharmacy Quality Management System consistent with CareTria’s Corporate Quality Management System requirements, NABP, URAC, ACHC, FDA, DEA and client quality expectations.- Own SOP/OWI lifecycle management, document control, record retention, and change control consistent with 21 CFR 211 Subpart B and quality system principles of 21 CFR 820.- Lead quality metrics, management review, and continuous improvement initiatives.
Regulatory & Accreditation Compliance- Ensure compliance with NABP, URAC, ACHC, state Boards of Pharmacy, DEA regulations, USP <800>, USP <1079>, DSCSA, and applicable sections of 21 CFR Part 211.- Prepare for and support inspections and audits (Boards of Pharmacy, NABP, URAC, ACHC, manufacturers, clients).
Deviation, Investigation & CAPA Oversight- Facilitate process deviation investigations, root cause analysis, and CAPA in alignment with 21 CFR 211.192 and Part 820 quality system expectations.- Ensure CAPAs are risk-based, effective, and documented.- Support client presentations and interactions relating to CAPAs and quality oversight
Operational Quality Oversight- Implement quality controls across fulfillment, dispensing support activities, packaging, labeling, cold chain, storage, and distribution.- Partner with Operations to embed error prevention and standardized workflows.
Cross-Functional Collaboration- Collaborate with Operations management to translate clinical risk into operational controls.- Partner with IT/IR on systems impacting data integrity, labeling, and workflow controls.
- Bachelor’s degree required; advanced degree preferred.- 5–7 years of experience in Quality Operations, Quality Systems, or Regulatory Quality in a FDA regulated or specialty pharmacy environment.- Experience supporting inspections, audits, investigations, and CAPA programs.- Working knowledge of NABP, URAC, 21 CFR Part 211, and quality system principles aligned with 21 CFR Part 820.
Preferred Qualifications
- Certified Quality Manager / Organizational Excellence (CQM/OE)- Certified Quality Auditor (CQA)- Six Sigma Green Belt or Black Belt- Experience with electronic QMS platforms- Experience supporting controlled substance programs or DEA audits