Manager, Pharmaceutical Repackaging Stability ProgramMaine Staffing • Augusta, ME, US

Manager, Pharmaceutical Repackaging Stability Program

Maine Staffing • Augusta, ME, US

2 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.

Responsibilities include :

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
GMP Compliance

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

Proficiency with Laboratory Information Management Systems (LIMS), electronic quality systems, statistical software

Demonstrated expertise in conducting OOS / OOT investigations

Experience with method transfer and method verification processes

Strong problem-solving, analytical, and critical thinking skills

Excellent written and verbal communication skills

What is expected of you and others at this level includes :

Managing department operations and supervising professional employees

Participating in the development of policies and procedures

Ensuring employees operate within guidelines

Interacting with subordinates, peers, customers, and suppliers

Anticipated salary range : $105,500 - $145,700. Bonus eligible : Yes. Benefits include medical, dental and vision coverage, paid time off plan, and more.

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.

Create a job alert for this search

Program Manager • Augusta, ME, US