Quality Assurance & Regulatory Operations Lead

Cencora; Shakopee (MN); On-site; USD 85,000 - 115,000; Full time

Job summary

Cencora in Shakopee, MN is seeking a Quality and Regulatory Compliance professional to manage the Quality Management System (QMS) and GDP compliance for the site. The role ensures adherence to applicable state and federal regulations and acts as a liaison with regulatory agencies.

You will drive quality improvement, support inspections, and lead CAPA and change-control activities while promoting a culture of quality across the facility. This is a full-time, on-site position with travel up to 10%.

Qualifications

• Maintains Quality Management System (QMS) and GDP compliance per local and federal rules.
• Conducts regulatory inspections, investigations, and information requests as needed.
• Promotes understanding of USP 1079 (GDP), data integrity and Good Storage, Distribution and Transportation practices.

Responsibilities

• Maintain, execute, and monitor the BU Location’s QMS and GDP compliance.
• Monitor licensure and registrations; liaise with regulatory agencies.
• Lead inspections, investigations, and information requests.
• Conduct Quality, Health & Safety, Security and Regulatory Assessments.
• Drive a culture of Quality and train staff on QMS principles.
• Implement annual Quality Objectives and CAPA processes.
• Perform RCA investigations and risk management activities.
• Use metrics and trends to drive improvements and cost savings.

Skills

Quality management

GDP knowledge

Regulatory compliance

Data integrity

Documentation practices

Training & mentoring

Quality auditing

Risk management

Lean Six Sigma

MS Office

Education

Bachelor's degree in Life Science or related field

Tools

Microsoft Office Suite

Job description

Cencora in Shakopee, MN is seeking a Quality and Regulatory Compliance professional to manage the Quality Management System (QMS) and GDP compliance for the site. The role ensures adherence to applicable state and federal regulations and acts as a liaison with regulatory agencies.

You will drive quality improvement, support inspections, and lead CAPA and change-control activities while promoting a culture of quality across the facility. This is a full-time, on-site position with travel up to 10%.