JOB SUMMARY: The Senior Quality Manager is responsible for the Quality Assurance (QA) activities involving QA Document Control, Training, Executed Batch Records, Reviewing Incoming Materials Inspection, Investigations, and Corrective and Preventive Actions. The Senior QA Manager interacts with clients for quality related issues. The Senior Quality Manager is involved in regulatory inspections.

MINIMUM REQUIREMENTS FOR EDUCATION, TRAINING AND EXPERIENCE :

1. Must be skilled in the use of computers, software and spreadsheets.
2. Must have strong organizational skills and ability to prioritize, schedule and multi-task.
3. Must have a minimum of 10 years supervisory/management and/or project management experience in a pharmaceutical company.

4.  PreviosPrevious experience in the review of validation (process, IOPQ) protocols and repots is preferable.

5. Bachelor’s degree in Pharmaceutical-related science.
6. Minimum of 15 years industry experience in a cGMP environment. Devices are a plus.
7. Knowledgeable in FDA cGMPs (21 CFR, 211, 820, and /or other 600); ISO 9001 and 13485 a plus.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES: Responsible for the management staff members in QA.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.