Project Quality and Risk Lead

2 weeks ago

Harrow, United Kingdom Parexel Full time
Harrow, Middlesex, United Kingdom

Job ID R

Category Quality Management

ABOUT THIS ROLE:


Due to a growing portfolio, we are currently looking for
Project Quality and Risk Lead to be based in the UK with flexible working hours.


Job Purpose:


The
Project Quality and Risk Lead assumes the lead (with support of LM or Mentor) of Quality oversight responsibility and partners with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state.

Provide quality expertise to support operations, leadership and clients enabling the safeguarding and maintenance of patient safety, data integrity and regulatory compliance The Project Quality and Risk Lead I is acting as Risk Manager being responsible to coordinate Critical to Quality (CtQ) identification, risk identification, evaluation and controls.

This position can also be part of a global project management team Project Quality and Risk Lead I assigned to projects will collaborate closely with the broader PQRM groups and other quality teams.


The key accountabilities:

  • Client Liaison: Effectively communicate with internal and external customers as well as third party vendors. Prioritize effectively and respond to urgent quality requests within team or from sponsor. Serve as the pointofcontact for the client quality representatives for projects or accounts.
  • Lead and facilitate the risk management process for assigned projects: Facilitate or lead projectlevel risk management, along with data management, safety, delivery and other areas as applicable. Work with operational teams, functional leads and SMEs to identify, categorize, score and develop mitigations. Confirm agreed mitigations have been integrated into functional project plans. Assess effectiveness of mitigations with functional leads. Encourage documenting lessons learned. Consult experienced PQRL or LM if needed
  • Lead and facilitate identification, investigation, and remediation of quality issues: Triage quality issues in electronic quality management system (eQMS) ensuring appropriate classification. Participate in the initial assessment of Serious Breach of GCP. Assist QI team members in developing containment actions. Facilitate Route Cause Analysis (RCA) Meeting & provide guidance on RCA process using various methodologies. Facilitate development of robust corrective and preventive actions (CAPA). Support assessment of CAPA effectiveness as necessary with QI team and action owners. Consult experienced PQRL or LM if needed
  • Analyze key risk indicators and investigate risk signals: Navigate dashboards to identify risk signals. Investigate signals by performing associated Risk Signal Evaluations (RSE) using available tools. Communicate identified risk to project team providing RSE data and other supporting information. Facilitate identifying the potential root cause. Assist team in developing robust mitigation plan. Assess effectiveness of mitigation plan. Consult experienced PQRL or LM if needed.
  • Assist with preparations, conduct, and response/action plan development for audits/inspections: Support audit/inspection preparation including helping team set priorities and reviewing key documents. Provide onsite or remote support as needed. Host audits remotely and onsite as requested Lead project team to investigate root causes. Facilitate RCA Meeting & provide guidance on RCA process. Review all audit/inspection responses prior to final QA review if necessary. Consult experienced PQRL or LM if needed
  • Provide quality advice: Provide realtime quality advice to enable project teams to deliver firsttime quality. Consult SMEs including other quality experts when necessary to resolve. Review and investigate possible projectlevel SOP deviations as requested by project teams. Consult experienced PQRL or LM if needed
  • Partner with project teams to achieve and maintain an inspectionready state: Provide guidance on maintaining inspectionready documentation for assigned projects. Review/update of storyboards for assigned projects as part of inspection preparation, where applicable. Encourage project team to use storyboard to record pre[1]developed responses to a situation not explained through the TMF. Review storyboards for completeness periodically to ensure inspectionreadiness
  • Identify areas for continuous improvement of the

Quality Management System:
Identify changes in scope and liaise with Project Leader. Provide feedback via the appropriate channel when gaps or issues are identified with Parexel processes. Propose ideas to PQRM leadership related to departmental efficiencies, potential improvements, or innovations.

  • Maintain compliance with Parexel standards: Comply with required training curricula. Accurately complete timesheet as required. Submit expense reports as required by SOP. Update CVs as required by SOP. Comply with Parexel processes, ICH-GCPs and other applicable requirements
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