Manager, QA (IC role)

Job Overview

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

Summary Of Responsibilities

• Oversees designated global audit programs for compliance with the master audit plan, (procedures, execution, QC, compliance to process, etc.)
• Identifies the scope and leads global audits and associated audit team.
• Facilitates prioritization of global projects for risk-based audits.
• 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.
• Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance and Quality Assurance (RC and QA) processes.
• 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.
• All other duties as needed or assigned.

Qualifications (Minimum Required)

Experience (Minimum Required)

Preferred Qualifications Include

Physical Demands / Work Environment

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Skills Required

process improvement initiatives, GXP roles, GVP audits, industry quality systems standards