Regional Quality Manager, PET Manufacturing

Cardinal Health; Albuquerque (NM); Sur place; USD 120 000 - 171 000; Plein temps

Avantages offerts par ce poste

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Wages access with myFlexPay

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Résumé du poste

Cardinal Health PET Manufacturing Services seeks a Senior Quality Leader to direct QA across its PET manufacturing sites in the United States. You will oversee raw materials, batch reviews, product disposition, investigations and change controls while ensuring regulatory compliance and product quality.

The role requires extensive knowledge of FDA CGMPs, validation practices, and strong leadership to mentor QA staff. Travel to multiple sites (50-75%) is expected, with relocation if necessary.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• 8-12 years of experience, preferred.
• 2-5 years of experience in the Pharmaceutical Industry preferred; 1-3 years in a quality management role preferred.
• Thorough knowledge of FDA regulatory requirements, CGMP and quality system requirements.
• Knowledgeable in validation practices and principles.
• Excellent interpersonal, organizational and communication skills.
• Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations).
• Ability to travel to all assigned sites (50%-75%).
• Must be located near PET facility or relocation may be required.

Responsabilités

• Provides overall direction and management of the QA function that supports assigned PET manufacturing sites in the United States.
• Oversees all QA activities including raw material storage, batch record review, product disposition, investigations and change controls.
• Provides guidance and training to QA staff on document verification, validation protocols/reports and regulatory compliance.
• Ensures identity, strength, quality and purity of drug product released at sites.
• Ensures raw materials and finished products meet specifications.
• Reviews production records and releases finished products.
• Ensures procedures are followed and investigations are completed for any deviations.
• Provides regional QA coverage across assigned sites and regulatory interactions as needed.
• Implements and monitors quality performance measures and reports to the Director, Quality.
• Collaborates with Area Manager to support PET network objectives.
• Identifies opportunities to improve efficiency and cost-effectiveness.

Connaissances

Quality management

FDA regulatory knowledge

Leadership

MS Word/Excel/PowerPoint

Formation

Bachelor’s degree or equivalent

Outils

MS Word

PowerPoint

Excel

Description du poste

Cardinal Health PET Manufacturing Services seeks a Senior Quality Leader to direct QA across its PET manufacturing sites in the United States. You will oversee raw materials, batch reviews, product disposition, investigations and change controls while ensuring regulatory compliance and product quality.

The role requires extensive knowledge of FDA CGMPs, validation practices, and strong leadership to mentor QA staff. Travel to multiple sites (50-75%) is expected, with relocation if necessary.