Clinical Quality Management Lead

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Date: Jul 16, 2019

Location: Raleigh, North Carolina, US

Clinical Quality Management Lead

Summary

The Global Clinical Sciences and Operations Quality Management Lead (GCSO QML) will lead/support GCSO in developing and maintaining its clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated. Activities include all aspects of clinical studies that are managed by GCSO and requires a focus on Good Clinical Practice (GCP), Good Laboratory Practices (GLP), and Pharmacovigilance (PV) regulations and guidance. This includes conducting impact assessments of emerging regulations or inspection trends related to clinical trials.

The GCSO QML will educate, organize, and coordinate information exchange with stakeholders at a global and local/regional level in alignment with the GCSO objectives and geographical footprint. As such, the GCSO QML will drive a culture of continuous quality improvement, using quality by design principles, and will liaise closely with Clinical Quality Assurance.

 

Major Accountabilities

  • Lead and/or support GCSO quality and compliance infrastructure development; assist with creation/revision of appropriate quality and compliance policies, SOPs, processes, and best practices as needed
  • Work in collaboration with Clinical Quality Assurance, Patient Safety,  Regulatory Affairs, strategic partners, and other stakeholders to ensure compliance with ICH GCP, GLP, PV and relevant local and international regulations and to ensure inspection readiness.
  • Own the GCSO Quality Management System (QMS) which includes quality planning and quality control. Drive recommendations for continuous quality improvement by leveraging industry benchmarking.
  • Participate in risk management planning with Clinical Quality Assurance
  • Represent or ensure GCSO representation and preparation during audits/inspections (on-site at UCB by internal and external parties)

  • Lead improvement initiatives to improve quality and compliance processes and effectiveness in collaboration with stakeholders

  • Develop metric reports for GCSO management of all issues related to the outcome of audits
  • Stay abreast with GCP, GLP, regulatory, and industry trends. Share key information gathered via professional associations and conferences (upcoming regulations, best practices) within the GCSO Practice, Global Regulatory Affairs, and Clinical Quality Assurance.

  • Provide relevant GCP, GLP, and PV guidance and training to GCSO staff for all phases of clinical drug development.   
  • Partner at all levels, including but not limited to, GCSO Line Management for staff assignment and audit/inspection coordination and serve as a point of escalation for resource coordination.

  • Conduct  tracking and trending of SOP deviations in clinical studies and ensure the follow up on GCSO deviations with deviation owners

  • Manage CAPA activity for internal (system) audits and findings from any audits and inspections where findings are raised to UCB in conjunction with department managers and subject matter experts. This includes CAPA tracking and monitoring for timely closure.

  • Manage TrackWise process on behalf of GCSO.

  • Partner with colleagues/others to (proactively) identify and mitigate compliance risks, resolve potential compliance observations and escalate critical compliance risks to upper management.

  • Ensures and/or facilitates that relevant acceptance testing for electronic systems used in clinical studies, such as IXRS, is performed and completed as appropriate

  • Represent GCSO in clinical team meetings and discussions as needed

  • All other duties as assigned

 

Technical knowledge

  • Excellent working knowledge of GCP, GLP, and PV-related requirements, proficiency of regulatory and ICH guidelines

  • Detail oriented with Quality Assurance and/or Clinical Development background with analytical and problem-solving skills, including application of root cause analysis

  • Ability to work effectively in a fast-paced environment with sense of urgency and proactivity

  • Ability to analyze and reconcile moderate-to-complex compliance issues independently and in a group setting

  • Knowledge of Trackwise preferred

  • Good analytical and investigation skills

  • Project management skills; excellent planning and organizational skills

  • Ability to prioritize based upon the compliance and patient safety risk

  • Ability to proactively identify critical issues, propose mitigation strategies, and escalate issues, when necessary, to senior management

  • Accountable for the compliance of all activities in scope of responsibilities

  • Strategic and results focused - ability to overcome obstacles and achieve key outcomes, ability to challenge the status quo in a constructive manner

  • Integrity - overriding commitment to integrity and high standards in self and others

Communication

  • Excellent communication and interpersonal skills - ability to effectively communicate (oral and written) to UCB sites, partners, vendors, and all levels of the organization

  • Good presentation and training skills

  • Fluent in English both speaking & writing

  • Ability to effectively build partnerships and networks (internally and externally) effectively- identifies opportunities and takes actions to build effective relationships within team and with other areas

  • Ability to present complex projects and issues to senior management

Problem Solving

  • Proactively identify, lead and resolve problems. This behavior requires independent thinking and innovative generation of ideas/solutions, coupled with an awareness of the appropriate communication technologies.

  • Self-driven (start the analysis of situation and come up with proposals and solving issues) and analytical (logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions)

  • Pragmatic analytical mind-set to understand global and complex compliance issues

  • Negotiation skills and ability to influence key decisions using strong interpersonal skills

  • Able to cope with stressful situations and drive tangible actions, issue resolution, and decisions


Job Segment: Manager, Clinic, CAPA, Pharmacovigilance, Quality, Management, Healthcare

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