Regional Manager, Quality Management

Cardinal Health

. Provides overall direction and management of the QA function supporting assigned PET manufacturing sites in the United States .

Posted 9/23/2026full-timeUnited StatesSeniorLead💰 $105,100 - $150,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance management within the Pharmaceutical Industry, ensuring compliance with FDA regulations and good manufacturing practices. Proficient in validation practices, quality system requirements, and effective leadership to drive team performance and operational excellence.

Highest-signal resume keywords

Quality Management ExperienceFDA Regulatory KnowledgeValidation PracticesLeadership SkillsPharmaceutical Industry Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality System RequirementsGood Manufacturing PracticesValidation ProtocolsBatch Record ReviewProduct DispositionInvestigationsCorrective ActionsStatistical AnalysisTrend AnalysisOperational Management

Soft Skills

Interpersonal SkillsOrganizational SkillsCommunication SkillsMotivational SkillsTeam Leadership

Tools & Technologies

MS WordMS PowerPointMS Excel

Industry Keywords

Pharmaceutical IndustryFDA ComplianceControlled EnvironmentsQuality AssurancePET ManufacturingRadiation Safety Training

About the role

Key responsibilities & impact

Provides overall direction and management of the QA function supporting assigned PET manufacturing sites in the United States
Oversees raw material storage, batch record review and approval, product disposition, investigations, remediation, validation protocols and site records management
Advises, guides and trains QA staff on validation protocols/reports, investigations, procedures and change controls
Provides oversight of the identity, strength, quality and purity of released drug products
Ensures raw materials and finished products meet specifications
Reviews production records and releases finished products
Ensures procedures are followed and errors or specification failures are investigated and corrected
Ensures regional quality coverage at assigned sites
Interacts with regulatory agencies and ensures timely closure of regional FDA commitments
Implements and monitors site quality performance measures and reports them to the Director, Quality
Advises management and personnel on systems, plans, specifications, methods and procedures
Assesses complaints, investigations, change controls and stability failures to identify trends and develop corrective actions
Collaborates with Area Managers and the PET network to build strategic alliances and meet deadlines
Identifies efficiency opportunities and manages monetary assets and resources for cost effectiveness
Ensures customers have a positive experience and meets or exceeds customer expectations
Approves moderate change controls, initiates investigations, directs corrective actions, develops training and revises quality procedures
Makes hiring decisions, approves personnel issues, deploys goals and performance evaluations
Manages department operations and supervises professional employees and support staff
Participates in policy and procedure development and resolves operational or project issues
Works onsite at a PET manufacturing facility with 50%-75% travel

Requirements

What you’ll need

Bachelor’s degree in related field, or equivalent work experience, preferred
8-12 years of experience, preferred
2-5 years of experience in the Pharmaceutical Industry preferred
1-3 years of experience in a quality management role preferred
Thorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and quality system requirements
Knowledgeable to validation practices and principles
Excellent interpersonal, organizational and communication skills
Demonstrated leadership and the ability to motivate and influence others
Proficiency with MS Word, PowerPoint and Excel (statistics, graphing, presentations, etc.)
Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices
Ability to travel to all assigned sites (50%-75%)
Must be located near PET facility or relocation may be required
Candidate must be flexible to work different shifts or schedules based on business need
Work hours may be subject to change
Employees handle radioactive materials and receive training to keep radiation exposures within regulatory guidelines

Benefits

Comp & perks

Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs
Bonus eligible