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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.

Quality Manager, 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 Quality Manager, you will partner with Global Data Management/Clinical Database Programming or Biostatistics/Statistical Programming teams focusing on investigating and analyzing first-time quality, robust risk and issue management and supporting an inspection-ready state. You will provide Quality expertise on Clinical Trials, through the execution of Quality SOP's to support operations, leadership, clients and patients.

Key Accountabilities:
  • Work with quality & operational management to identify, analyze, report and advise on areas of risks on projects
  • Provide transparency to compliance with quality expectations to operational management (via metrics, reports, meeting attended/chaired)
  • Lead project teams to investigate more complex issues and root causes
  • Facilitate development of robust CAPA for more complex issues
  • Contribute to critical issue resolution by providing expert quality advice & direction - serve as eQMS SME
  • Review SOP deviations considering client & Parexel processes, regulatory requirements and guidance
  • Support assessment of potential Serious Breach of GCP & developing containment actions
  • Support audit/inspection preparation including helping teams set priorities, reviewing key documents and responses
  • Establish * maintain strong partnerships with operational management - other quality business units and line managers to ensure continuous improvement & regulatory compliance
  • Deputize for the Head of Data Services, Project Quality Risk Management as assigned, representing specific topics

Qualifications

Skills:
  • Able 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.
  • Expert analytical critical thinker, able to focus on identifying potential and real issues, investigating root causes, brainstorming, imagining alternatives and assessing the effectiveness of actions
  • Expert skills 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
  • Ability to effectively mentor less experienced members of staff.
  • 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. Master’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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