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Quality Assurance Opportunities at PAREXEL

By being hired into one of our Quality Assurance jobs at PAREXEL International, you’ll be a key member of the PAREXEL International team. Professionals in Quality careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A job in Quality at PAREXEL International may be waiting for you!

Project Quality & Risk Lead II

Job ID 50592BR USA - Any Region - Home Based
Serve as primary project quality expert, point of contact and support to project team leadership throughout the project. Manage the Quality Evaluation (QE) workflow. Communicate results to the project team (PL, FLs). Provide support with quality issue management, audits and inspections, and project quality and risk consultancy as required. Assess operational execution using a risk-based approach to verify adherence to standards and assist with remediation when required. Facilitate quality related interactions with clients.
  • Verify compliance with GxP guidelines/regulations, PAREXEL procedures and requirements, and sponsor requirements.
  • Actively participate in key internal / client project meetings. Schedule and lead the project related Quality Forums.
  • Act as primary point of contact for communications with client quality representatives.
  • Provide quality advice and support with investigation of Quality Issues (QIs) and support of QI management including classification of issues, assist in determination of root cause and consultation on appropriateness of corrective and preventive actions.
  • Provide audit and inspection support for assigned projects, including, advising the project team during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on project related audit/inspection responses generated by project team members.
  • Represent Quality Management in audits and inspections as required. Supporting audits and inspections as host/co-host/other support, as assigned.
  • Evaluate the quality status of a project by reviewing applicable project quality metrics. Identify and evaluate potential risks and quality issues in collaboration with project team leadership and other relevant parties.
  • Fulfill the mentor role for Project Quality & Risk Leads and provide guidance, as assigned
  • Serve as quality consultant for assigned accounts to senior project leadership personnel and assist with the oversight of quality aspects of the client program.
  • Review key portfolio documentation and oversee the collection, reporting and evaluation of portfolio quality metrics. Coordinate Project Quality & Risk Leads assigned to the client as needed.
  • Provide audit and inspection support for portfolio. Review and provide feedback on portfolio related audit/inspection responses. Represent Quality Management in audits and inspections as assigned.

Qualifications

Skills:
  • Excellent interpersonal, verbal and written communication skills
  • Client focused approach to work
  • Substantial clinical trials experience
  • Leadership and/or project management skills and experience
  • Ability to handle several highly complex projects simultaneously and entire programs, potentially spanning multiple strategic business units (SBUs)
  • Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning
  • Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
  • Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization
  • IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions
  • Ability to travel approximately 30% - 50%
Education:
  • Bachelor of Arts or Bachelors of Science

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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