PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.
If you have pharma experience with managing CAPA's in an aseptic environment, we want to meet you!
The CAPA Manager will own and implement the CAPA Program and manage documentation for Notice of event (NOE), Nonconformance Investigations and CAPA. Develop, execute and manage projects and release activities within the defined scope. Expedite and coordinate a multitude of interrelated project activities within the daily constraints with changing priorities to ensure the successful completion of improvement initiatives. Manage the Quality Engineers at each facility.
1. Responsible for implementing and maintaining the effectiveness of the quality system.
2. Collaborate with Supply Chain, Marketing, Operations and IT management to establish and gain consensus on project goals, objectives and deliverables.
3. Provide subject matter expertise and training; as needed; to other functional areas.
4. Maintain project control and timely execution to which changes to scope; issues and risks will affect initiatives.
5. Must lead projects, identify opportunities, define and financially justify projects, use good project management to manage cross functional team activities with the problem solving methodology. Remove and elevate project barriers
6. Develop and execute Investigational and CAPA plans obtaining authorized resources to ensure all activities are performed timely.
7. Communicate progress by producing CAPA project plans and provide timely and accurate CAPA status.
8. Gather and analyze data for root cause analysis. Coordinate and drive efforts to assure CAPAs are opened and completed appropriately
9. Maintain close communication and collaboration with key stakeholders to adjust priorities as needed and ensure that initiatives stay on time.
10. Coordinate resources to ensure project needs are addressed and effectively assign tasks and deliverables to team members based upon their abilities.
11. Supervises and motivates Quality Engineers
12. Quality Management: Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1. Bachelor's Degree in Science or related field required.
2. Minimum of 5-7 years' experience in Quality, pharmaceutical experience required
3. Minimum of 3 years of exposure to a CAPA program, Root Cause Investigations and Nonconformance processing.
4. Thorough understanding of the Governmental requirements in a sterile processing environment. Aseptic experience required.
5. Minimum of 5 years' experience with managing or supervising employees
6. Demonstrates understanding of quality assurance in a regulated (FDA, DEA, ISO) environment.
7. Proven ability to bring projects to a conclusion.
8. Computer skills in spreadsheets and databases required.
9. Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills.
TRAVEL: 10 to 20% Travel required
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