Regional Manager, Quality Management

Cardinal Health; United States; On-site; USD 120,000 - 171,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

FlexPay

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health PET Manufacturing Services is seeking a Director of Quality Management to lead the QA program across PET radiopharmaceutical manufacturing sites in the United States. You will oversee QA operations, release of products, investigations, and change controls while ensuring compliance with cGMP and regulatory expectations.

The role requires strategic leadership, deep FDA knowledge, and the ability to travel 50-75% to site locations.

Qualifications

• 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, GMPs and quality systems.

Responsibilities

• Provides overall direction and management of the QA function that supports assigned PET manufacturing sites in the United States.
• Responsible for all Quality Assurance functions including raw material storage, batch record review/approval, product disposition, investigations and remediation of manufacturing issues.
• Provides guidance and training to QA staff on document verification, validation and change controls.
• Oversees product identity, strength, quality and purity at sites and ensures materials meet specifications.

Skills

Leadership

Regulatory knowledge

Communication

Travel readiness

Education

Bachelor's degree in related field

Tools

MS Word

PowerPoint

Excel

Job description

What Quality Management contributes to Cardinal Health Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Management provides strategic oversight, leadership and direction within the Quality function. Cardinal Health PET Manufacturing Services is responsible for manufacturing PET radiopharmaceuticals to enhance patient treatment through improved disease diagnosis, staging, and monitoring.

Responsibilities

• Provides overall direction and management of the QA function that supports their assigned PET manufacturing sites in the United States
• Is responsible for all Quality Assurance functions including but not limited to: raw material storage activities, batch record review and approval, product disposition, investigation and remediation of manufacturing issues according to procedure, compliant investigation, execution of validation protocols and site related records management
• Provides advice, guidance and training to QA staff in the verification and approval of documents and processes including but not limited to: validation protocols / reports, investigations, procedures and change controls
• Providing general oversight to ensure the identity, strength, quality and purity of the drug product released at their sites
• Ensuring that all raw materials and finished product meet specifications
• Ensuring the review of production records and release of finished product at their assigned sites
• Ensuring that all procedures are followed and that all errors and failures to meet specification are appropriately investigated and corrected at their sites
• Ensuring regional quality coverage at all assigned sites
• Interacts with regulatory agencies, as necessary and ensures the closure any regional FDA commitments on time and its related documentation/objective evidence appropriate
• Ensure that the procedures are properly followed and adequate for their intended use
• Implements and monitors quality performance measures for the site and reports them to the Director, Quality in a timely manner
• Interacts with and provides advice to management and other personnel in the establishment of systems, plans, specifications, methods and procedures
• Assess data collected (complaints, investigations, change control, stability failures, etc.) to identify trends and develop corrective actions where needed to ensure compliance with cGMP’s and regulatory requirements
• Collaborates with their assigned Area Manager and others to build strategic alliances within the PET network; negotiates to build broad-based support and/or persuades others in order to meet deadlines
• Identifies opportunities to improve efficiency while providing flawless transactions, services and products; manages monetary assets and other resources to optimize cost effectiveness
• Ensures that customers have a positive experience; commits to meet or exceed customer expectations

Qualifications

• 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

What is expected of you and others at this level

Manages department operations and supervises professional employees, front line supervisors and/or business support staff Participates in the development of policies and procedures to achieve specific goals Ensures employees operate within guidelines Decisions have a short term impact on work processes, outcomes and customers Interacts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior management Interactions normally involve resolution of issues related to operations and/or projects Gains consensus from various parties involved

Schedule

Onsite role at a PET manufacturing facility Candidate must be flexible to work different shifts or schedules based on business need Work hours may be subject to change 50% - 75% travel

Work Environment

The primary work environment consists of a manufacturing pharmacy which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

Salary

Anticipated salary range: $119,500.00-$170,700.00

Bonus

Bonus eligible: Yes

Benefits

• 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

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH) is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. We are a crucial link between the clinical and operational sides of healthcare, delivering end‑to‑end solutions and data‑driving insights that advance healthcare and improve lives every day. With deep partnerships, diverse perspectives and innovative digital solutions, we build connections across the continuum of care. With more than 50 years of experience, we seize the opportunity to address healthcare's most complicated challenges — now, and in the future.