Clinical Quality Operations Manager - Remote

Overview

In partnership with the Clinical Quality Operations Lead (CQOL) and Head of CQO, the CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area. This includes operational quality management and inspection management activities. The CQOM will oversee headquarters clinical quality operations and support clinical trial teams within the assigned therapeutic area, to proactively embed quality into our Company's sponsored trials, ensure adequate vendor oversight and address any quality issues as needed.

The incumbent will be accountable for the development of quality plans to implement “quality by design” within clinical development programs, using a risk-based approach. The incumbent will be accountable for the overall strategy for maintaining ongoing inspection readiness as well as preparing for, management and follow up of regulatory inspections.

• The Clinical Quality Operations Manager is accountable for overseeing the strategic implementation of “quality by design” principles in assigned clinical trials.
• The CQOM will develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT.
• The CQOMs within a specific therapy area will collectively and periodically (e.g. quarterly) perform a TA-level review of quality plans and risk mitigation approaches to identify emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
• The CQOM will facilitate and oversee responses to audit and inspection observations, analyze data across therapy areas to identify signals and trends, and develop and implement process improvement strategies.
• In partnership with the CQOL, develop skillsets to recognize and respond to new and emerging risks through technology, including maintaining knowledge of Good Clinical Practice with respect to digital data management.
• Build and enable effective working relationships with key stakeholders to ensure role clarity and business effectiveness, including ongoing partnership with QA and acting as the link between Clinical Development, study teams, global functions and regional study management.
• Contribute to standardization of Clinical Quality Operations procedures, tools and templates for consistency across the study lifecycle.
• Provide comprehensive oversight of all activities delegated to third parties.

• Facilitating and monitoring CTT oversight of vendors
• Development, review and revision of quality agreements with business partners
• Ensuring essential elements of the quality management system are in place for studies conducted with non-commercial organizations (e.g. NGO, government or academic institutions).

• Maintain current regulatory inspection knowledge related to GCP inspections by worldwide regulatory agencies, including FDA, EMA, MHRA, and other authorities. Lead and support GCP inspections; may be assigned as Point of Contact for specific regulation areas.
• Lead cross-therapy-area oversight of the TA, including filing schedules, potential future inspections and ongoing inspection preparation activity.
• Develop, update and maintain GCP inspection procedures and guidelines; contribute to policy, SOPs and training materials.
• Develop strategy for management and support of GCP inspections to ensure professional, proactive, and compliant outcomes.
• Ensure cross-functional teams are informed and prepared to support Regulatory Health Authority inspections worldwide.
• Collaborate to maintain and QC global inspection tracking of inspections, findings, responses and CAPAs.
• Act as SME and primary point of contact for Inspection Management; escalate significant findings to Senior Management.
• Develop inspection management plans for assigned inspections in collaboration with Cross-Functional Teams.

• Ensure all actions related to audits and inspections are implemented timely and track CAPA and regulatory commitments with evidence of completion.
• Maintain repository of evidence for inspections; provide guidance for country-level inspections requiring HQ input.