Project Quality & Risk Lead II
Parexel
Buenos Aires, Argentina
hace 5 días

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.

We are currently looking for a Project Quality & Risk Lead to work remotely in Colombia

As a Project & Quality Risk Lead you will :

  • Partner with operational delivery teams focusing on first-time quality, robust risk, and issue management, and maintaining an inspection-ready state.
  • Provide quality expertise through the execution of quality SOPs to support operations, leadership, and clients.
  • Analyze key risk indicators and investigate risk signals by performing, reporting, and coordinating risk-based quality evaluations for assigned projects using dashboards, reports, metrics, and other available tools.
  • Facilitate and drive the risk management process for assigned projects using the available tools.
  • Facilitate identification, investigation, and remediation of quality issues as assigned using available tools and methodologies.
  • Provide oversight, transparency, and tracking of quality issues for assigned studies.
  • Assist with preparations, conduct, and response / action plan development for audits / inspections as assigned.
  • Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements, and input of appropriate subject-matter experts.
  • Partner with project teams to achieve and maintain an inspection-ready state including storyboard oversight.
  • Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the roles of Portfolio / Client Quality Lead.
  • Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested
  • Mentor PQRLs as needed.
  • Qualifications

    This position needs someone who has :

  • Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
  • Analytical skills focus on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.
  • Ability to develop professional, collaborative relationships both internally and with the client.
  • Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues.
  • Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge.
  • Ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus.
  • Quality-oriented with an attention to detail, taking initiative, ownership and accountability for deliverables.
  • Ability to manage the complexity of a matrix environment while valuing the importance of teamwork.
  • Ability to travel 10%
  • 5 years’ experience in late phase clinical research Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development
  • Expertise with ICH-GCP principles
  • English proficiency (written and oral)
  • Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred.
  • Master’s Degree in a science, technology or industry-related disciple preferred.
  • We offer you an excellent work environment while you work from home, as well as several development opportunities that you will get on your journey through our company.

    In addition, you will have the opportunity to interact with outstanding professionals of different levels and cultures located around the world.

    Looking forward to receiving your application

    Best luck

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