What Quality Assurance 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 Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary

This role is responsible for the oversight and management of the stability program for repackaged pharmaceutical products, ensuring compliance with current Good Manufacturing Practices (cGMP) and relevant regulatory guidelines. This role demands a strong understanding of stability testing methodologies, quality control principles, data analysis, and a proven track record in a GMP environment. This role helps ensure the quality, safety, and efficacy of products through the development, implementation, and maintenance of robust stability protocols, testing procedures, and quality systems.  The manager will lead cross functional collaborations and possess exceptional communication and interpersonal skills to effectively collaborate with internal business partners and external stakeholders.

Responsibilities

Program Oversight: Develop, maintain, and oversee the stability program and related studies, ensuring alignment with cGMP requirements and industry best practices.Repackaged Product Stability: Manage the stability program for all repackaged products, ensuring appropriate stability studies are designed and executed to support the shelf life and storage conditions of these products. This includes developing specifications, protocols and acceptance criteria for repackaged products.Documentation: Develop, review, and approve stability protocols for repackaged pharmaceutical products in accordance with regulatory requirements and industry standards.  Generate, review, and revise Standard Operating Procedures (SOPs), protocols, reports, and other relevant documentation to ensure compliance with cGMP and regulatory standards.Contract Laboratory Management: Manage third party laboratories executing stability protocols, including oversight of data integrity, adherence to cGMP and performance monitoring.Stability Sample Management: Oversee the shipment of stability samples from repackaging facilities to laboratories and ensuring appropriate sample submission documentation.Data Analysis and Trending: Perform in-depth stability data trending analysis, identify data anomalies, and compile comprehensive reports, ensuring data integrity and compliance with cGMP.  Manage the preparation and review of Annual Product Reviews to identify trends, assess product performance, and ensure continued product quality.Container-Closure Selection: Oversee the selection and qualification of appropriate container-closure systems (specifically foil and film for unit dose blisters) to ensure product integrity and stability throughout shelf-life.OOS/OOT Investigations: Lead and conduct thorough Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations related to stability data, including root cause analysis, hypothesis testing, and implementation of corrective and preventive actions (CAPAs) to prevent recurrence. Ensure investigations are initiated and completed in a timely manner, adhering to established timelines and regulatory expectations. Ensure investigations are well-documented, scientifically sound, and compliant with cGMP requirements.  Serve as the primary point of contact for escalating quality issues and concerns to the drug manufacturer, ensuring timely resolution and communication.Method Transfer/Verification: Responsible for all method transfer and method verification activities related to stability testing, ensuring successful implementation and validation of analytical methods across multiple laboratories. This includes protocol development, data review, and troubleshooting.Budget Management: Develop and manage the budget for stability testing activities, ensuring cost-effective utilization of resources.Risk Management: Conduct risk assessments related to stability and implement appropriate mitigation strategies.Team Leadership: Lead, mentor, and develop a team of quality professionals. Provide clear direction, set performance expectations, and provide regular feedback. Foster a collaborative and high-performing team environment.  Effectively delegate tasks and responsibilities to team members, ensuring appropriate workload distribution and skill development opportunities.Cross-Functional Collaboration: Collaborate with project managers, Inventory Management, Sourcing, and other Quality Assurance team members to ensure seamless execution of stability studies and related activities.Communication: Effectively communicate with internal and external stakeholders, providing updates on stability study progress, addressing technical issues, and ensuring alignment with project timelines and cGMP requirements. Ensure timely responses to inquiries and requests for information.GMP Compliance: Ensure all stability activities are performed in compliance with cGMP regulations, company policies, and industry standards. Participate in internal and external audits, and implement corrective actions as necessary.

Qualifications

Bachelor's degree in a relevant scientific field preferred (e.g., Chemistry).Minimum 8 years of experience in a GMP-regulated pharmaceutical quality oversight environment, with a focus on stability testing and data analysis preferred.Prior experience in pharmaceutical repackaging, contract manufacturing, or generics is a plus.In-depth knowledge of FDA regulations, ICH guidelines, USP monographs, and other relevant regulatory requirements related to stability testing and cGMP compliance.Proficiency with Laboratory Information Management Systems (LIMS), electronic quality systems, statistical software and other relevant software applications used for data analysis and reporting, along with good documentation practices.Demonstrated expertise in conducting OOS/OOT investigations, including root cause analysis and CAPA implementation. Experience managing investigations to meet established timelines.Demonstrated expertise with inspections and audits from customers and regulators through active engagement and critical participation.Experience with method transfer and method verification processes.Experience in developing container closure strategy to ensure suitable packaging systems to achieve desirable outcomes is a plus.Proven ability to lead and motivate a team, driving a culture of compliance, quality, and continuous improvement while balancing business goals and operational efficiency.Drives core culture principles of accountability and ownership throughout the team and peers.Experience in utilizing risk-based assessment methodologies that leverage mechanistic insights that may impact the quality and efficacy of drug product stability.Strong problem-solving, analytical, and critical thinking skills, with the ability to identify and resolve complex issues related to stability testing and cGMP compliance in real time.Excellent attention to detail, organizational skills, and the ability to manage multiple projects simultaneously.Exceptional written and verbal communication skills, with the ability to effectively communicate complex scientific information to both technical and non-technical audiences, and to build strong relationships with internal and external business partners.Effectively communicates and collaborates with senior leaders in the organization clearly and succinctly, taking into account corporate priorities and the goals of different departments and groups.Ability to onboard and engage with external customers and vendors and forge strong working relationships to deliver excellent customer experience.Thorough understanding of cGMP principles and practices, including data integrity requirements.

What is expected of you and others at this level

Manages department operations and supervises professional employees, front line supervisors and/or business support staffParticipates in the development of policies and procedures to achieve specific goalsEnsures employees operate within guidelinesDecisions have a short term impact on work processes, outcomes and customersInteracts with subordinates, peers, customers, and suppliers at various management levels; may interact with senior managementInteractions normally involve resolution of issues related to operations and/or projectsGains consensus from various parties involved

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

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/Affirmative Action 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.

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