Quality Issue Lead - FSP
Not Disclosed•Full-TimeRemote
location_on2264, East Bismarck Expressway, Bismarck, Burleigh County, North Dakota, 58504, United States
Parexel FSP is seeking Issue Leads in the US or Canada to drive Quality Event (QE) case management. This role is critical for ensuring that investigations are conducted thoroughly, adhering to strict timelines and compliance requirements. The Issue Lead oversees the efficiency of GCP investigations, leveraging data to assess team performance and execute necessary interventions.
In this position, you will triage submitted cases to determine if they meet the QE threshold and assess the need for expedited reporting to senior management or regulatory authorities. You will be accountable for managing confirmed Quality Events through the entire investigation lifecycle, including conducting root cause analysis and ensuring all documentation is accurately captured in the eQMS system.
The role involves initiating appropriate escalations for Critical QEs, ensuring leadership is promptly informed. Once an event is qualified, you will lead the investigation to confirm chronology and details, applying root cause, gap, and due diligence methodologies. This includes reviewing relevant SOPs, assembling cross-functional teams with subject matter experts, and contributing to process development and technology improvements in collaboration with PFE Digital.
Qualified candidates will be considered for employment without regard to legally protected status. For more information on our application process, please visit the Parexel careers portal.
Parexel is an equal opportunity employer. We are committed to fostering a diverse and inclusive environment where all employees can thrive. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Work model: Remote
2264, East Bismarck Expressway, Bismarck, Burleigh County, North Dakota, 58504, United States
Bismarck, North Dakota
Strong background in continuous improvement methodology (i.e., Lean Six Sigma)
Skills: GCP, GXP, Root Cause Analysis, Gap Analysis, Due Diligence, Sop, Capa, Lean Six Sigma.
Education: Master's or MBA preferred with 6+ years experience.