Senior Quality Assurance Auditor

hace 3 semanas


Xico, México Icon Plc A tiempo completo

At Icon Plc, we're driven by a shared vision to advance and improve patients' lives. Our diverse teams enable us to deliver excellence to our clients and patients at every touch-point.

We're looking for a talented Senior Auditor Quality Assurance to join our dynamic and supportive environment. In this role, you will play a pivotal part in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

  • Utilizing a strong knowledge of regulatory expectations and industry knowledge, provide expert consultancy and compliance advice within Icon Plc for current and emerging technology related topics, such as eClinical Systems and AI.
  • Perform a variety of audit activities, including internal process audits with a technology component, technology vendor audits, computerized system and equipment audits.
  • Conduct Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems.
  • Participate as a Technology related Subject Matter Expert during inspections, sponsor audits, and in support of Quality Issues.
  • Mentor and train junior staff.

**Requirements:**

  • Bachelor's degree in Life Sciences, Pharmacy, IT, or related field; advanced degree preferred.
  • Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, healthcare, or CRO industry.
  • Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues spanning multiple systems and/or business areas.
  • Proven auditing experience of computerized systems, processes, and vendors used in a clinical development and manufacturing setting.
  • In-depth knowledge of data integrity, computerized system validation, delivery/service models, oversight frameworks, and emerging trends.
  • Familiar with regulations and guidance governing clinical trials and drug development.
  • Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.
  • Ability to travel more than 20%.


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