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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Senior Auditor, Quality Assurance

Job ID 65741BR Lithuania - Any Region - Home Based
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Parexel are looking for a Senior Auditor within Quality Assurance to be homebased in Lithuania, Poland, Czech Republic, or UK.

The Quality Assurance (QA) Senior Auditor will have an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws. The role will also obtain an in-depth understanding of Parexel procedures and appropriate Parexel processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors. In liaison with Quality Assurance (QA) Management and staff, this role will also provide direction and coordination for project activities related to assigned areas and provide advice on regulatory compliance.

The Role:
  • Collect and review responses to audit observations and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained
  • Work with client QA and Parexel Operations to plan and manage a global program of audits.
  • Ensure required audits are delivered in accordance with clients’ requirements and Parexel/ client procedures as applicable.
  • Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities.
  • Support QA Management to analyze audit activities and provide metrics to relevant parties (QA, Operations, Procurement).
  • Provide advice on regulatory compliance to internal/external clients, Parexel management, and staff with regards to the implementation of GxP and safety/PV requirements, and implementation of appropriate regulatory requirements.
  • Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate.

Qualifications

Knowledge and Experience:
  • Minimum of 2 years’ experience in Late Phase quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, or safety/pharmacovigilance, pharmacy, or laboratory, including sound experience of applicable GxP auditing – experience mustbe within a clinical trial environment
  • Background in data management or biostats within clinical trial environment highly desirable
  • Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
  • Experience with using computer systems and software, including Microsoft Office
  • Auditors must be detail oriented, able to maintain a ‘big picture’ / overview on the project / business
  • Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically.
Skills:
  • Ability to rapidly learn, understand and apply applicable Parexel and client procedures
  • Client focused approach to work
  • Ability to develop good working relationships with a culturally diverse group of Parexel and client personnel
  • Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings and training sessions
  • Ability to mentor / train auditors and other personnel
  • Excellent organizational, analytical, problem solving and negotiation skills
  • Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions
  • Accurate and detail oriented
  • Excellent time management skills with the ability to prioritize workload and manage multiple and varied tasks / projects with enthusiasm
  • Flexible attitude to work assignments and new learning and the ability to adjust to changing priorities and unforeseen events
  • Ability to diplomatically address sensitive issues confidentially and professionally
Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
  • Master’s degree in a science, technology or industry related discipline, preferred.

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