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McKesson · 1 month ago

Director, Quality Operations Distribution

USA, VA, Richmond

Full-time

Hybrid

Director/Executive

$140K/yr - $180K/yr

10+ years exp

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. The Director of Quality Operations, Distribution is responsible for leading all quality-related activities for wholesale distribution and ensuring compliance with regulatory standards while driving continuous improvement across the organization.

BiopharmaBiotechnologyHealth CareInformation TechnologyPharmaceutical

No H1B

Responsibilities

Ensure regulatory and operational standards are established, executed, and monitored within distribution centers

Oversee temperature monitoring and documentation for product storage areas

Lead investigations into complaints and CAPA for product and process quality issues, including diversion and illegitimate products

Prepare distribution centers for regulatory inspections and host external audits from suppliers and regulatory bodies

Develop and monitor KPIs, compile compliance reports, and provide recommendations for improvement

Act as a training resource for cGxP and ISO compliance; maintain up-to-date SOP training records

Qualification

Quality AssuranceRegulatory ComplianceLeadership ExperienceCGxP KnowledgeFDA Inspection ExperienceData AnalyticsChange ManagementCommunication SkillsProblem-Solving SkillsStrategic Thinking

Required

Bachelor's degree or higher in Engineering, Science, or related field

10+ years in leadership roles within scientific fields or Quality Assurance in distribution or commercial manufacturing of medical devices/pharmaceuticals

Clear understanding of cGxPs

Experience leading FDA, Board of Pharmacy, and/or NABP inspections

Expertise in regulatory requirements for distribution QA (CFR 205, 820, 210, 211, DSCSA, Hazmat, Cold Chain)

Strong verbal and written communication skills

Organizational, problem-solving, and decision-making abilities

Strategic thinking and change management skills

Must be authorized to work in the U.S

Sponsorship is not available for this position