Senior Quality Assurance Auditor/Compliance Manager

3 weeks ago

Shanghai, Shanghai, China Parexel Full time

Transforming Quality Excellence

Overview

Parexel is seeking a highly skilled Senior Quality Assurance Auditor/Compliance Manager to lead and coordinate internal audits and audit programs, ensuring the highest standards of quality and compliance across the organization.

Key Responsibilities

  • Plan and conduct complex audits, including project-related audits, system audits, supplier qualification and re-qualification audits, and safety/pharmacovigilance audits.
  • Coordinate internal global process/system audits, developing necessary tools and reporting outcomes and trends to process owners and QA Senior Management.
  • Escalate quality and compliance issue trends to QA Senior Management and relevant operational functions.
  • Review audit reports, responses, and other audit and program deliverables to ensure consistent high quality.
  • Develop and maintain network contacts with other QA professionals.
  • Act as QA Lead for billable audit programs or client accounts, overseeing audits, creating and maintaining the Audit Process Plan, and coordinating billable audits across regions.
  • Provide strategic feedback and trending for Regulatory Inspectorates and client audits.
  • Travel internationally for audits as required.

Requirements

  • Ability to work independently and as part of a team, with excellent communication and leadership skills.
  • Strong analytical and problem-solving skills, with the ability to identify and implement process improvements.
  • Proven experience in quality assurance and compliance, with a strong understanding of regulatory requirements.
  • Ability to develop and maintain relationships with internal and external customers, with excellent interpersonal and customer service skills.

What We Offer

Parexel offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to attracting and retaining the best talent in the industry, and offer a competitive compensation and benefits package.

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