Pharma Quality Operations Leader

McKesson; Shepherdsville (KY); On-site; USD 98,000 - 164,000; Full time

Job summary

McKesson is seeking a Senior Quality Operations Specialist to act as the onsite quality liaison for Operations at the Clermont Distribution Center in Shepherdsville, KY. The role focuses on embedding quality culture, reducing compliance risk, and driving continuous improvement across the network.

The candidate should bring 7+ years in pharmaceutical quality or regulated distribution, strong knowledge of cGMPs, DSCSA, and experience in a matrixed organization.

Qualifications

• 7+ years of progressive experience in pharmaceutical quality or regulated distribution environments.
• Knowledge of FDA regulations and DSCSA requirements with 3+ years in QA.
• Experience in a large, matrixed organization with cross-functional exposure to Quality, Operations, Compliance, and Technology.

Responsibilities

• Serve as the primary Quality liaison to Operations at the Clermont DC.
• Maintain onsite presence to foster a culture of quality, compliance and collaboration.
• Oversee investigations, CAPA development and regulatory defensibility.
• Create and edit SOPs/WIs to enhance efficiency and compliance.
• Support audit and inspection readiness and participate in regulatory inspections.

Skills

cGMP knowledge

DSCSA knowledge

Quality Assurance

Written & verbal communication

Regulatory compliance

Education

Bachelor's degree in a scientific/quality field

Advanced degree preferred

Tools

TrackWise

MasterControl

eQMS software

Job description

McKesson is seeking a Senior Quality Operations Specialist to act as the onsite quality liaison for Operations at the Clermont Distribution Center in Shepherdsville, KY. The role focuses on embedding quality culture, reducing compliance risk, and driving continuous improvement across the network.

The candidate should bring 7+ years in pharmaceutical quality or regulated distribution, strong knowledge of cGMPs, DSCSA, and experience in a matrixed organization.