PharMEDium Services, LLC, an AmerisoureBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.
The Senior Quality Manager will lead a staff of Quality Managers, Supervisors and Technicians that perform daily quality assurance activities and functions, as the facility DEA Officer the Senior Quality Manager will ensure DEA compliance. The Senior Quality Manager will ensure that staff performs routine tasks in a timely manner according to established Standard Operating Procedures through direct observation and review. RESPONSIBILITIES:
- The Senior Quality Manager will coordinate with the Director of Quality Operations and Facility General Manager and assure that PharMEDium's core values are continually emphasized and kept in the forefront of facility operations.
- Will be responsible for all daily quality operations within the facility. Ensures compliance to procedures, governing regulations and addresses non-compliance issues.
- As the leader of Quality in the Center the Senior Quality Manager will set the tone for quality processes and services to deliver safe compounded preparations to hospital customers.
- Will conduct internal audits of processes, systems and procedures.
- Participate in cross-functional teams to identify effective corrective and preventive actions to improve Lean process quality.
- Working with Facility General Manger will assure timely closure of audit items.
- Will initiate SOP revisions as needed to assure compliance, continuous improvement of overall operation.
- Drive the collection and compilation of data for submission of all DEA related reports which include ARCOS reports, Procurement Quota Requests and Year End Reports.
- Conduct root cause analysis for compounding errors and in-process errors generated at the facility during all phases of the Center processes.
- Coordinate and schedule testing of all compounded services for the on-going stability and on-going sterility monitoring programs with the appropriate contract labs (ensure product is produced and shipped to the appropriate lab in a timely manner).
- Perform review of quality related documents generated at the Sugar Land facility.
- Coordinate efforts with the Director of Quality Operations in the management of the Facility Testing Laboratory. Will ensure the day to day operation of the lab is meeting its testing goals in a precise, accurate and efficient manner.
- Other duties and responsibilities as assigned.
- Bachelor's Degree in Science or related field.
- Aseptic processing experience desired.
- Minimum of 10-15 years' experience in Quality, or related field in the healthcare or pharmaceutical industry.
- 5-7 years Management experience.
- Demonstrated understanding of quality assurance in a regulated (FDA, DEA, ISO) environment.
- Thorough understanding of the Governmental requirements in a sterile processing environment.
- Computer skills in word processing, spreadsheets and databases required.
- Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills