Manager, Pharmaceutical Repackaging Stability Program

Quality Assurance Manager

Quality Assurance contributes to Cardinal Health by developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. 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. The manager will lead cross-functional collaborations and possess exceptional communication and interpersonal skills to effectively collaborate with internal and external stakeholders.

Responsibilities

Program oversight, repackaged product stability, documentation, contract laboratory management, stability sample management, data analysis and trending, container-closure selection, OOS / OOT investigations, method transfer / verification, budget management, risk management, team leadership, cross-functional collaboration, communication, and GMP compliance.

Qualifications

Bachelor's degree in a relevant scientific field, minimum 8 years of experience in a GMP-regulated pharmaceutical quality oversight environment, in-depth knowledge of FDA regulations, ICH guidelines, USP monographs, proficiency with LIMS, electronic quality systems, statistical software, demonstrated expertise in conducting OOS / OOT investigations, experience with inspections and audits, experience with method transfer and method verification, experience in developing container closure strategy, proven ability to lead and motivate a team, drives core culture principles of accountability and ownership, experience in utilizing risk-based assessment methodologies, strong problem-solving, analytical, and critical thinking skills, excellent attention to detail, organizational skills, exceptional written and verbal communication skills, ability to onboard and engage with external customers and vendors, thorough understanding of cGMP principles and practices.

Anticipated salary range : $105,500 - $145,700. Bonus eligible : Yes. Benefits include 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.

Application window anticipated to close : 11 / 30 / 2025. If interested in opportunity, please submit application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate's geographical location, relevant education, experience and skills and an evaluation of internal pay equity. 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.