Quality Audit Team Manager

About the position

The Quality Audit Team Manager provides oversight of one or more of the quality audit teams and manages day-to-day operations, supervising team members. Additionally, the Quality Audit Team Manager is accountable for ensuring training needs of their team are addressed, and for the regulatory compliance and policy & procedural compliance of the team.

Responsibilities

• Establish and monitor lab section specialization for Audit Team members
• Oversee the continuous improvement processes efforts of the Audit Team
• Train, supervise, and mentor the Audit Team
• Lead Audit Team meetings
• Review and trend general adverse quality events (unexpected results, retests, deviations, amended reports)
• Review SOPs in MasterControl
• Review protocols, raw data, validations, or final reports as needed
• Perform GLP audits as needed
• Perform Internal Audits as needed/requested by the Internal Audit Coordinator
• Perform other duties as assigned.

Requirements

• Demonstrated experience in a Supervisory capacity leading QA teams
• 2+ years of leadership experience with a Bachelor's Degree in a relevant Life Science
• 4+ years of directly related experience with an Associate's Degree or HS Diploma
• At least one of the following: Supervisory Training or experience, Business Training or experience, MIT M.B.A.
• At least one of the following Quality Requirements: NRM or NLM Quality Certification, CQE, CBA, or CQA, Sterilization Specialist Certification, Other job specific certifications (as approved by the career board)