Regional Quality Manager, PET Manufacturing

Cardinal Health, Inc.; Las Vegas (NV); On-site; USD 120,000 - 171,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Flexible spending accounts (FSAs)

Disability coverage

Parental leave

Job summary

Cardinal Health, Inc. is seeking a Regional Quality Manager to lead QA across PET manufacturing sites in the United States, ensuring regulatory compliance and product quality. You will manage investigations, change controls, and personnel, while partnering with regulators and internal teams.

The role requires 8–12 years in QA/regulated environments, strong leadership, and travel up to 75% to support multiple sites. Onsite PET facility work and a broad benefits package are provided.

Qualifications

• Bachelor’s degree in related field or equivalent work experience
• 8–12 years of experience, preferred
• 2–5 years in pharmaceutical industry preferred
• 1–3 years in a quality management role preferred
• Thorough knowledge of FDA regulatory requirements, cGMPs, and quality systems
• Knowledgeable about validation practices and principles
• Excellent interpersonal, organizational and communication skills
• Demonstrated leadership and ability to motivate others
• Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, etc.)
• Ability to travel to all assigned sites (50%–75%)
• Must be located near PET facility or relocation may be required

Responsibilities

• Provides overall direction and management of the QA function supporting assigned PET manufacturing sites in the United States
• Oversee all QA functions including raw material storage, batch review and approval, product disposition, investigations and remediation
• Provide guidance and training to QA staff on document verification and process approvals
• Ensure identity, strength, quality and purity of drug product released at sites
• Ensure raw materials and finished products meet specifications
• Review production records and release finished product
• Ensure procedures are followed and investigate/correct any deviations
• Provide regional quality coverage at all sites
• Interact with regulatory agencies and close FDA commitments on time
• Develop and implement quality performance measures and report to Director of Quality
• Collaborate with Area Manager to build strategic alliances within PET network
• Identify efficiency improvements and manage resources for cost-effectiveness
• Ensure customer satisfaction and meet/exceed expectations
• RQM authority to approve change control documents, initiate investigations, deliver training, develop procedures, hiring decisions, approvals of personnel issues, and performance evaluations

Skills

Quality management

Regulatory knowledge

Leadership

Communication

Travel readiness

Education

Bachelor’s degree in related field

Tools

MS Word

PowerPoint

Excel

Job description

Cardinal Health, Inc. is seeking a Regional Quality Manager to lead QA across PET manufacturing sites in the United States, ensuring regulatory compliance and product quality. You will manage investigations, change controls, and personnel, while partnering with regulators and internal teams.

The role requires 8–12 years in QA/regulated environments, strong leadership, and travel up to 75% to support multiple sites. Onsite PET facility work and a broad benefits package are provided.