Manager, Pharmaceutical Repackaging Stability ProgramVermont Staffing • Montpelier, VT, US

No longer accepting applications

Manager, Pharmaceutical Repackaging Stability Program

Vermont Staffing • Montpelier, VT, US

3 days ago

Job type

Full-time

Job description

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. 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 include :

Program Oversight : Develop, maintain, and oversee the stability program and related studies.
Repackaged Product Stability : Manage the stability program for all repackaged products.
Documentation : Develop, review, and approve stability protocols and other relevant documentation.
Contract Laboratory Management : Manage third party laboratories executing stability protocols.
Stability Sample Management : Oversee the shipment of stability samples.
Data Analysis and Trending : Perform stability data trending analysis and compile comprehensive reports.
Container-Closure Selection : Oversee the selection and qualification of container-closure systems.
OOS / OOT Investigations : Lead and conduct investigations related to stability data.
Method Transfer / Verification : Responsible for method transfer and verification activities.
Budget Management : Develop and manage the budget for stability testing activities.
Risk Management : Conduct risk assessments related to stability and implement mitigation strategies.
Team Leadership : Lead, mentor, and develop a team of quality professionals.
Cross-Functional Collaboration : Collaborate with various team members to ensure seamless execution of stability studies.
Communication : Effectively communicate with internal and external stakeholders.
GMP Compliance : Ensure all stability activities are performed in compliance with cGMP regulations.

Qualifications include :

Bachelor's degree in a relevant scientific field preferred.

Minimum 8 years of experience in a GMP-regulated pharmaceutical quality oversight environment.

In-depth knowledge of FDA regulations, ICH guidelines, USP monographs, and other relevant regulatory requirements.

Proficiency with Laboratory Information Management Systems, electronic quality systems, statistical software, and other relevant software applications.

Demonstrated expertise in conducting OOS / OOT investigations.

Experience in developing container closure strategy.

Proven ability to lead and motivate a team.

Strong problem-solving, analytical, and critical thinking skills.

Excellent attention to detail, organizational skills, and the ability to manage multiple projects simultaneously.

Exceptional written and verbal communication skills.

Anticipated salary range : $105,500 - $145,700. Bonus eligible : Yes. Benefits include medical, dental and vision coverage, paid time off plan, health savings account, 401k savings plan, access to wages before pay day, flexible spending accounts, short- and long-term disability coverage, work-life resources, paid parental leave, and healthy lifestyle programs.

Application window anticipated to close : 11 / 30 / 2025. If interested in the opportunity, please submit your application as soon as possible. The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including geographical location, relevant education, experience and skills, and an evaluation of internal pay equity.

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Program Manager • Montpelier, VT, US