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Jobs at Parexel

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®.

Sr Quality Specialist, Project Quality and Risk Management

Job ID 71283BR USA - Southeast - Home Based
Home Based or Office Based, North Carolina (need to be within driving distance to Durham, NC)

As a Sr Quality Specialist with Parexel you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. You will provide quality expertise through the execution of quality SOP's to support operations, leadership and clients.

Key Accountabilities:

You will manage the relationship with Operations, with limited Line Manager or experienced data services PQRM assistance.
  • Assist with establishing & maintaining a strong partnership with operational management assigned partners, other Quality and business functions (e.g. Risk Management, Project Quality & risk Leads) and with Line Manager to ensure continuous improvement and regulatory compliance
  • Provide transparency to compliance with quality expectations to operational management (via metrics, reports, meeting attended/chaired)
  • Champion the Quality Management System within both the group and the Operational teams via Operational management
  • Provide input to Quality forums, to facilitate meaningful discussion that leads to action on key risk areas
  • Contribute to initiatives to accomplish PQRM's goals
Provide Quality input to audits/inspections with limited Line Manager support or Data Services assistance
  • Support audit/inspection preparation including helping team set priorities and reviewing key documents
  • Provide onsite (office) or remote support as needed
  • Lead project team to investigate root causes
  • Facilitate development of robust CAPA
  • Contribute to critical issue resolution by providing expert quality advice and direction
  • Serve as an eQMS SME
Provide quality consultancy as assigned
  • Respond to consultancy requests to enable project teams to deliver first-time quality
  • Review and approve SOP deviations using ICH-GCP, Parexel processes, regulatory requirements
  • Consult SMEs including other quality experts when necessary to resolve issues
Facilitate identification and remediation of Quality Issues (QIs) as assigned
  • Ensure triage of relevant quality issues in electronic quality management system (eQMS) ensuring appropriate classification, as assigned
  • Support initial assessment of Serious Breach of GCP developing containment issues
  • Escalate issues to leadership as necessary
Develop and cultivate transparent quality relationship on assigned Partnerships, to achieve and maintain inspection-ready performance with limited Line Manager assistance.
Facilitate the Risk Evaluation process.
Maintain compliance with Parexel standards and regulatory requirements

Qualifications

Skills:
  • Emerging ability to lead without explicit authority
  • Self-management: independent, takes initiative, proactive & organized
  • Focused on quality results - attention to detail and first time quality
  • Persistent - does not give up!
  • Sees the big picture & understands how the pieces fit together
  • Excellent interpersonal, verbal and written communication skills.
  • Growing skills as an analytical critical thinker, able to focus on identifying potential and real issues, investigating root causes, brainstorming, imagining alternatives and assessing the effectiveness of actions
  • Skilled in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identity areas of risk, trends and aggregate issues
  • Ability to plan, organize others, prioritize and manage workload independently
  • Adaptable to changing environments, able tot think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge
  • Cultural awareness with the ability to thin and work, globally
  • Able to travel as needed for the position
Knowledge and Experience:
  • Experience in a Quality/Regulatory/Quality Assurance role following GCP/ICH E8
  • Experience in one or more areas of Data Management, Biostatistics, Programming and/or Medical Writing.
  • Significant experience is required in either a functional area or Quality but ideally, both
  • Understanding of clinical technology solutions is preferred
Education:
  • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience.
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

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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