Senior Clinical Audit Manager

2 semanas atrás

Brasil beBeeClinicalAudit Tempo inteiro US$152.000 - US$209.000
Senior Clinical Audit Manager Role

This is a key leadership position responsible for leading clinical audit programs, collaborating with clinical operations, suppliers, and functions. It involves developing and maintaining annual risk-based clinical audit schedules, preparing and conducting clinical audits, and reporting results to senior global quality compliance leaders.

The ideal candidate will have a strong background in life sciences or engineering, with a minimum of 10 years' experience working in pharmaceutical and medical device industries, including 5 years as a Lead Auditor.

Key Responsibilities:

  • Developing and maintaining the annual risk-based clinical audit schedule following global audit program requirements.
  • Preparing and conducting clinical audits, including investigator sites, research organizations, and internal processes/systems.
  • Presenting and reporting audit results concisely and logically both verbally and in writing to senior global quality compliance leaders.
  • Maintaining responsibility for and oversight of clinical audits conducted by contractors.
  • Providing clinical compliance expertise and supporting the generation of clinical audit metrics.
Requirements

The successful candidate will possess:

  • A bachelor's degree in life science or engineering discipline required; an advanced degree preferred.
  • Minimum 10 years' experience working in pharmaceutical and/or medical device industries, with 5 of these years as a Lead Auditor.
  • 2 years' experience with regulatory inspections management.
  • 1-5 years program and people management experience, working in a matrix organization.
  • Demonstrated ability to work as a leader with strong communication and relationship building skills.
  • ASQ certification or other relevant auditor certification a plus.
  • Advanced knowledge of and experience with clinical regulations, GCP requirements, and relevant standards.
What We Offer

A competitive compensation package, including a base salary range, discretionary bonuses, and comprehensive benefits packages.

We offer medical and dental coverage, basic life insurance, short-term and long-term disability insurance, business travel accident insurance, flexible spending accounts, educational assistance programs, time-off benefits, paid holidays, paid parental leave, and family and medical leaves of absence.

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