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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. 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. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

Technology Quality Assurance Auditor

Job ID 68146BR USA - Any Region - Home Based
Home Based, US

As a Technology Auditor, Quality Assurance you will have an in-depth understanding and knowledge of appropriate GxP technology compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes to conduct audits and provide advice to internal and external clients. You will effectively lead, manage, develop, and implement assigned projects, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects with excellent time management skills, and possess the ability to handle confidential information diplomatically.

In addition, you will assure compliance to GxP regulated processes and standards as the fundamental baseline for technology validation and delivery across Parexel. You will consults with the various business units to assure quality across all technology business units to meet critical to quality criteria.

You will provide GxP regulatory expertise to ensure technology units adhere to established standards and quality expectations. Audit on technology projects to identify and mitigate risks and prevent quality concerns.
Assure quality of selection of technology solutions in support of delivery of products and services to Parexel clients.

Specialized Area:
  • Conduct risk-based technology audits across all SBUs, all GxP regulations and phases of Clinical Research including, but not limited to, product development audits, Computerized System Validation and audits, system audits audit supplier audits
  • Provide support for regulatory inspections and high-risk sponsor audits
  • Provide Quality representation on Serious Breach Assessments, Information Security Incidents and technology related policies and procedures

Key Accountabilities:
  • Work independently and as part of the QA team
  • Facilitate sponsor audits/regulatory inspections, as assigned
  • Fosters a good working relationship with internal and external clients
  • Working knowledge and expertise of PAREXEL policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed
  • Promotion of compliance within the company
  • Plan and conduct audits, including global and complex assignments, delivering a written report within procedural time frames
  • Proactively provide input to management on audit plans/strategy
  • Proactively recognize areas for process/procedural improvements, providing input to management and taking the initiative, as appropriate
  • Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
  • Mentor and assist with training of less experienced auditors
  • Contribute to the information provided to QA management to summarize quality issues arising from audits and other related activities, as requested
  • Be familiar with GxP required computer system validation requirements
  • Maintain and/or develop records/documents for assigned areas
  • Travel on assignment, possibly up to 60%
  • Other duties as assigned

Qualifications

Skills:
  • Ability to develop relationships with a culturally diverse group of key stakeholders within PAREXEL and the client’s business
  • Excellent interpersonal, verbal, and written communication skills, including experience in making presentations at conferences, meetings, and training sessions
  • Excellent analytical skills
  • Ability to manage multiple and varied tasks, and prioritize workload
  • Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Accurate and detail oriented with excellent organizational skills
  • Ability to execute strategy and plans
  • High degree of flexibility and ability to adjust to changing priorities and unforeseen events
  • Team leadership abilities and positive attitude
  • Excellent knowledge of, and working experience with, regulations
  • Excellent problem solving and negotiation skills
  • Ability to work professionally with highly confidential information
  • Ability to work independently and consistently in a fast-paced environment
  • Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions
  • Experience with Microsoft based office applications and ability to learn internal computer systems

Knowledge and Experience:
  • Substantial experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing

Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
  • Bachelor’s degree in a science, technology or industry related discipline, preferred

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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