ROLE SUMMARY

The Clinical Quality Lead (CQL) is responsible for driving Level One quality for assets within specific categories by maintaining ‘quality’ line-of-sight for assets/protocols.  With this focus, the CQL 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, the CQL 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.

ROLE RESPONSIBILITIES

As CQLs are assigned to specific asset(s) within a category, responsibility includes:

• Level 1 GCP Quality support to clinical study teams
• IQMP Development and Oversight (Integrated Quality Management Plan) at study and asset level including integration within the Quality Management System (QMS)
• GCP Quality Oversight, including Escalation, Communication, and Governance

Responsibilities:

• 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 (QCA) within assets or CD&O process area and drive learnings across the asset and/or portfolio
• Lead Level 1 quality review/assessment during Due Diligence and/or Integration activities
• Oversee study-level quality risk management activities (including IQMP activity)
• Drive consistent implementation of IQMP across study teams
• Facilitate IQMP development
• Assess QTL implementation by ensuring that quality metrics are monitored and that quality deviations are identified and addressed in a timely and appropriate manner.
• 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
• Develop and present quality point of view at governance meetings
• Guide asset/study team on appropriate escalation pathways for quality concerns
• 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
• 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.

Qualifications

A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:

• BS with extensive experience in pharmaceutical industry
• MS/MBA with strong experience in pharmaceutical industry
• Ph.D./MD with moderate experience in pharmaceutical industry
• Extensive knowledge of ICH GCP and regulations in order to assess GCP situations and coordinate resolution activities across partner lines
• Expert knowledge, experience and expertise in clinical trial development, and operational quality management disciplines such as, quality and compliance assessments, quality assurance, CAPA management, deviation management, root cause analysis, audit and regulatory inspection process, and/or inspection readiness.
• Ability to build strong network/knowledge/relationships with internal/external stakeholders
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

This role can be site based or remote based.

Eligible for Employee Referral Bonus: YES