Fortrea

Fortrea

Clinical Quality Operations Manager, FSP

Durham · Senior · Part-time

Sponsorship not specifiedDetected 55 days ago
GCPProject ManagementNegotiationProcess ImprovementPerformance ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingGxP

About the role

  • Responsible for process and performance management related to the delivery of the operational function(s), as assigned.

Responsibilities

  • Operational Quality Management: The Clinical Quality Operations Manager is responsible for overseeing the strategic implementation of `quality by design` principles in assigned clinical trials.
  • 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 in order to identify any emerging signals or trends and provide relevant feedback to the CQOL and Head of CQO as appropriate.
  • This will include, but not be limited to: Facilitating and monitoring CTT oversight of vendors Development, review and revision of quality agreements with business partners (i.e. co-development of products with other pharmaceutical companies).
  • In addition, the CQOM will work with peers to analyse data across therapy areas in order to identify signals and trends and will then develop and implement appropriate process improvement strategies.
  • In collaboration with the CQOL, the CQOM will develop skillsets in order to be able to recognise and appropriately respond to new and emerging risks through the use of technology.
  • In particular this will include developing and maintaining a profound understanding of Good Clinical Practice with respect to digital data management (i.e. use of novel technology within clinical trials).
  • The CQOM will build and enable effective working relationships with key stakeholders in order to ensure and maintain role clarity and business effectiveness.
  • The CQOM is responsible for maintaining appropriate levels of knowledge and skill in order to effectively lead and support GCP inspections, worldwide.
  • Under the guidance of the CQO Lead, the CQOM may be assigned as Point of Contact (POC) for a specific area of regulations (e.g. FDA, EMA, NMPA, etc.).
  • Collaborate with other therapeutically aligned CQOM to provide comprehensive oversight of the TA.

Requirements

  • Minimum of 6 years of relevant experience in clinical research including at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.
  • Profound knowledge and understanding of clinical development programs, clinical trial processes as well as quality management systems and quality control tools is required.
  • Experience with delivering effective CAPA management solutions.
  • Experience with risk management tools and processes within the clinical quality framework.
  • Thorough knowledge of drug development process.
  • Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.
  • Relevant quality management experience: Detailed knowledge of all aspects of GCP guidelines and regulations.
  • Demonstrated ability to separate critical from non-critical GCP issues.
  • Experience with CAPA and risk management tools.

Skills

  • Demonstrated ability to work under pressure and requires minimal supervision.
  • Strong interpersonal and communication skills.
  • Strong negotiation skills and ability to influence stakeholders across functions.
  • Strong analytical skills.
  • Excellent planning and organizational skills.
  • Excellent oral, written and presentation skills.
  • Excellent communication, leadership, and project management skills.
  • ACRP-CP Certification strongly preferred Strategic thinker with strong problem-solving and analytical abilities.
  • Effective in cross-functional collaboration and inspection readiness.
  • Skilled in summarizing audit/inspection findings and delivering lessons learned.
  • Expert knowledge in clinical development, QMS, GCP/ICH, and global regulatory requirements.

Benefits

  • Develops the inspection management plan for each assigned and identified Regulatory Health Authority inspection, in conjunction with the applicable Cross-Functional Team.
  • Ensures repository of evidence in Documentum (containing evidence of CAPA and commitment completion, as well as other definitive inspection documentation) is complete for all Regulatory Health Authority inspections.
  • Provides input into GCP Quality and Compliance Council regarding the QMS, RACT, Quality Plans and Regulatory Health Authority inspections status and results, including escalation of overdue CAPA commitments.

Company info

  • We are currently seeking Clinical Quality Operations Manager!
  • This is a full-time role based in the United States.
  • Minimum of eight (8) years relevant clinical research experience in a pharmaceutical company/CRO.
  • Thorough project management, change management, line management experience, and quality control experience highly desirable.
  • Individual is familiar with on-site monitoring activities (including pre-study, initiation, routine monitoring, and closeout visits), with on-site monitoring experience being highly desirable.

Equal opportunity

  • Learn more about our EEO & Accommodations request here.

Visa & Work Authorization

  • Contributes to the development and/ or revision of Sponsor policies, SOPs and training materials
Apply directly at Fortrea →Create a free account for alerts like thisView Fortrea immigration profile

This listing is sourced directly from Fortrea's careers page and normalized into a canonical job model.