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Mgr. QA & Compliance                     Salary $100,000 - $135,000
Albany, NY                                                      Bonus Eligible - 15%

Submit resume to Greg Taylor - gtaylor@excelsiorsp.com
Refer to Job TE01588207-0729


Description
This individual will manage the total quality function of a plant to help ensure product quality and site compliance to FDA requirements. The primary role is to manage the quality assurance department, all associated office activities, auditing staff, QA Engineers and Supervisors for solid-dose and liquid manufacturing and packaging operations.  This includes supervision of 80 QA personnel and systems.  Responsibilites include:

• Ensures adherence to and compliance with established company quality policies, practices, SOPs and federal regulations.
• Monitor and promote Quality Awareness and Regulatory Compliance for the entire site.
• Participate in investigations of process deviations and assist in determining disposition for non-conforming bulk and finished product as well as packaged materials.
• Direct support for the staff will be necessary in terms of monitoring, planning & scheduling, and tracking all the necessary office responsibilities to meet the business requirements.

Requirements:
The ideal candidate will have:

• BS or BA preferably with related technical background.
• Minimum of 5 years experience in the pharmaceutical or similarly regulated industry, preferably in a Quality Assurance or Validation related position.
• Knowledge of regulatory environment.
• Excellent oral and written communication skills. Excellent organizational skills.
• Proven decision-making ability.
• Proven personnel development ability.
• Good presentation skills.