Sr Quality Specialist, Distribution

Job Description

The Senior Quality Assurance Specialist provides senior‑level quality oversight for Regional Distribution Center (RDC) operations and plays a critical role in ensuring compliance with FDA regulations, McKesson’s Quality Management System (QMS), and customer expectations. This role performs and approves product disposition activities, supports import and FDA-facing interactions, executes computer system validation (CSV) tasks, and partners with operations and cross-functional teams to drive consistent quality execution across the network.

Responsibilities

RDC Quality Operations & Product Disposition

• Provide senior‑level quality oversight for RDC operations to ensure compliance with FDA regulations, QMS requirements, and customer standards.

• Inspect, review, and release product for distribution in alignment with approved procedures and specifications.

• Place product on quality hold or quarantine when nonconformances, damage, regulatory concerns, or data integrity issues arise.

• Perform and approve product disposition decisions, including release, rework, rejection, or destruction, ensuring complete documentation and traceability.

• Oversee and support:

  • Incoming, in‑process, and outbound inspections

  • Product destruction reconciliation

FDA-Facing & Import Quality Support

• Serve as a primary quality contact for FDA import activities, including resolving import holds, exams, and information requests.

• Coordinate documentation required for product admissibility and partner with Quality Management, Trade Compliance, Operations, and external partners.

• Support inspection readiness and interact directly with FDA investigators during RDC inspections or follow‑up activities.

• Escalate regulatory or import‑related issues promptly and support related investigations.

Computer System Validation (CSV) & Data Integrity

• Serve as an SME for CSV activities involving WMS, ERP, eQMS, labeling systems, inspection systems, and other GxP computerized systems.

• Execute, review, and approve CSV lifecycle documentation, including:

  • Risk assessments and validation plans

  • IQ/OQ/PQ (or equivalent) testing

  • Validation summary reports and traceability matrices

• Provide quality oversight for computerized system change controls, ensuring proper risk assessment, validation, regression testing, and documentation.

• Perform and support data integrity activities, including:

  • User access reviews and re‑certifications

  • Verification of system outputs (labels, reports, electronic records)

  • Identification and escalation of data integrity risks

Regional & Cross‑Functional Support

• Provide quality support to multiple RDCs within the network as needed.

• Partner with Operations, IT, and Quality teams to ensure consistent quality processes and expectations across sites.

• Lead or contribute to regional quality projects, remediation activities, and continuous improvement initiatives.

General Responsibilities

• Participate in and/or lead quality workstreams for site and regional initiatives.

• Maintain flexibility to support extended hours, holidays, or weekends as required.

• Travel as needed to support RDC operations, audits, or regulatory activities.

• Perform additional Quality Assurance responsibilities as assigned.

Minimum Requirements

• 4+ years of relevant experience

Critical Skills

• Strong understanding of FDA regulations applicable to distribution operations.

• Demonstrated experience with product inspection, release, hold processes, and quarantine activities.

• Working knowledge of import compliance and support for regulatory inspections or audits.

• Hands-on experience with CSV activities for GxP systems.

• Solid understanding of data integrity principles and electronic records requirements.

• Ability to work independently and exercise sound quality judgment in fast-paced, high-stakes environments.

• Strong written, verbal, and interpersonal communication skills.

• Proven ability to collaborate cross‑functionally and manage competing priorities.

• Excellent attention to detail with strong documentation and organizational skills.

Education & Training

• Bachelor’s degree required; STEM strongly preferred.

• Proficiency in Microsoft Word, Outlook, and Excel.

• Training or experience in FDA‑regulated distribution, import compliance, or CSV is preferred.