Regional Quality Leader, PET Manufacturing

Regulatory Jobs; Nevada (IA, NM); Vor Ort; USD 120.000 - 171.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision

Paid time off

401k savings plan

myFlexPay access

FSAs

Disability coverage

Work-Life resources

Paid parental leaveHealthy lifestyle

Zusammenfassung

Cardinal Health is seeking a Regional Quality Manager to lead QA across PET manufacturing sites in the United States. The role ensures compliance, oversees investigations, and manages change controls while guiding staff and aligning with regulatory commitments.

Responsibilities include reviewing records, ensuring product quality, and collaborating with management to optimize site quality metrics. Travel to multiple sites is expected, with a focus on maintaining cGMP standards and safe operations.

Qualifikationen

• Bachelor’s degree in related field, or equivalent work experience.
• Thorough knowledge of FDA regulatory requirements and GMP.
• 8–12 years of experience in quality or regulatory roles preferred.
• Strong leadership and interpersonal skills for cross-site guidance.
• Willingness to travel 50–75% to PET manufacturing sites.

Aufgaben

• Direct and manage QA across PET manufacturing sites in the United States.
• Oversee raw material storage, batch review, product disposition and investigations.
• Provide training on validation, change controls and document approvals.
• Ensure product quality, regulatory compliance and timely closure of FDA commitments.
• Develop and monitor quality performance measures and report to Director, Quality.

Kenntnisse

Leadership

Regulatory knowledge

Quality management

Communication

Training

Travel ability

MS Word

PowerPoint

Excel

Ausbildung

Bachelor's degree

Tools

MS Word

PowerPoint

Excel

Jobbeschreibung

Cardinal Health is seeking a Regional Quality Manager to lead QA across PET manufacturing sites in the United States. The role ensures compliance, oversees investigations, and manages change controls while guiding staff and aligning with regulatory commitments.

Responsibilities include reviewing records, ensuring product quality, and collaborating with management to optimize site quality metrics. Travel to multiple sites is expected, with a focus on maintaining cGMP standards and safe operations.