Manager QA, External Audit

Overview

Manages and ensures proper execution of the audit and inspection programs.

What you'll do

• Oversee and lead execution of client audit, for-cause audit and regulatory inspection end to end activities.
• Ensure the consistent implementation, use and review of SOPs.
• Escalate issues to management in a timely manner, implementing appropriate solutions, including preventative actions.
• Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies.
• Analyze and interpret data to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes.
• Lead and effectively manage constructive crucial interactions with clients or regulatory agencies.
• Interpret applicable quality regulations/standards and create appropriate policies and procedures.
• Ensure Regulatory Compliance and Quality Assurance (RC and QA) management responsibilities, as indicated in applicable controlled documents, are followed.
• Conduct internal audits as directed, such as process/system and service provider quality assessment for qualification/requalification.
• All other duties as needed or assigned.

What you'll need

• A minimum of a bachelor's degree in Life Sciences (or equivalent Life Science experience); relevant and equivalent experience may be considered in lieu of educational requirements, and experience may be substituted for education.
• 10+ years of experience in regulatory environment (experience in GXP roles).
• Experience and regulatory expertise of industry quality systems/standards.
• Ability to interpret applicable regulations/standards.
• Experience in leading process improvement initiatives.
• Ability to communicate and negotiate with internal stakeholders effectively.

Details

• Some overtime and weekend work may be required.
• Travel required.