Quality & Regulatory Leader: GDP, Audits & Compliance

Cencora; Shakopee (MN); Vor Ort; USD 76.000 - 119.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision benefits

Training programs

Mentorship programs

Zusammenfassung

Cencora in Shakopee, MN is seeking a Quality & Regulatory Operations professional to maintain the QMS, ensure GDP compliance, and align with federal and state regulations. The role reports to the Regional Director of QRO and collaborates with regulatory agencies to support inspections and investigations.

Requires a four-year bachelor’s degree (Life Science or related) and at least four years of related experience; travel up to 10% may be required; Lean Six Sigma and data integrity knowledge are

Qualifikationen

• Requires a four-year bachelor’s degree or equivalent and 4+ years of related experience.
• Quality Management System (QMS) maintenance and GDP/compliance responsibilities.
• Regulatory liaison with local, state, and federal agencies; support inspections and investigations.

Aufgaben

• Maintain and monitor the quality management system (QMS) and GDP compliance.
• Ensure local, state, and federal regulatory licensure and registrations are current.
• Act as liaison with regulatory agencies; manage inspections and investigations.
• Lead quality, health & safety, security and regulatory assessments.
• Drive continuous improvement and annual quality objectives.
• Travel up to 10%.

Kenntnisse

Lean Six Sigma

Regulatory compliance

Documentation practices

Communication skills

Leadership

Problem-solving

Microsoft Office

Ausbildung

Bachelor's degree in Life Science

Tools

Microsoft Office

Jobbeschreibung

Cencora in Shakopee, MN is seeking a Quality & Regulatory Operations professional to maintain the QMS, ensure GDP compliance, and align with federal and state regulations. The role reports to the Regional Director of QRO and collaborates with regulatory agencies to support inspections and investigations.

Requires a four-year bachelor’s degree (Life Science or related) and at least four years of related experience; travel up to 10% may be required; Lean Six Sigma and data integrity knowledge are