Job Description

Quality Assurance - Clinical
Job Number: 21-09692
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance - Clinical for our client in Groton, CT.
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 

Position Overview:
  • Responsible for driving Level One quality for assets within specific categories by maintaining 'quality' line-of-sight for assets/protocols.
  • With this focus, the role brings deep knowledge of Level One quality issues and risk areas within assets and across clinical trial business process areas.
  • In partnership with the appropriate roles in Clinical Development & Operations, will ensure asset and study level quality oversight, drive quality risk management activities across an asset, and will be instrumental in ensuring that asset and study level information is appropriately incorporated within the GCP QMS.
  • Point person to stakeholders and asset teams for asset and study quality risk management, quality issues management and general GCP guidance.
 
Responsibilities:
  • As CQLs are assigned to specific asset(s) within a category, responsibility includes:
    • Level 1 GCP Quality:
      • Provide single point of accountability to clinical teams for GCP advice and guidance
      • Strategically utilize quality and compliance data to monitor portfolio quality and recognize potential risks and issues. Ensure project teams are aware of risks, issues and general quality state of asset/study. Analyze and interpret data from multiple sources to drive quality assessments
      • Partner with Analytics and Reporting on the development of quality metrics
      • Provide Level 1 portfolio quality expertise on SQE investigation teams, as needed
      • Design and execute Quality Compliance Assessments within assets or CD&O process area and drive learnings across the asset and/or portfolio
      • For persistently red metrics, guide project teams through a CAPA discussion identifying appropriate actions/remediations
      • Lead Level 1 quality review/assessment during Due Diligence and/or Integration activities
    • IQMP Development and Oversight (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System:
      • Oversee study-level quality risk management activities (including IQMP activity)
      • Drive consistent implementation of IQMP across study teams
      • Facilitate IQMP development to ensure that study teams:
      • Identify factors that are critical to quality and pre-specify appropriate quality metrics and identify high priority risks to quality and prospectively implement appropriate mitigation plans
      • Assess QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner.
      • Evaluate the quality of approved IQMPs through IQMP effectiveness reviews and/or IQMP QC reviews
      • Utilize QMS information, and integrate findings back into QMS, share learnings across assets and across CQL team
      • Provide feedback to IQMP BPO to continuously improve IQMP approach
    • Escalation, Communication and Governance:
      • Develop and present quality point of view at governance meetings
      • Guide asset/study team on appropriate escalation pathways for quality concerns
      • Escalate/communicate quality issues to:
      • Quality Center of Excellence
      • Governance committees (e.g. GCP QOC, RDM QCC)
      • IPLT /Process Quality Leads for process level issues
      • Advocate for study teams' continuous improvement feedback on business processes to BPOs
      • Communicate key quality information (e.g. inspection/audit learnings) across asset/study teams and serve as asset quality expert
    • Inspection Readiness and Preparation:
      • Provide Study Team Inspection Readiness (IR) guidance and support; lead teams through pre-submission IR deep-dive in partnership with Audit and Inspection Quality
      • Participate and guide teams with inspection preparation, conduct and response activities
      • Support teams during inspections.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
646-695-2942
Paul Quibuyen | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. 

Application Instructions

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