Project Quality And Risk Lead

ABOUT THIS ROLE

Due to a growing portfolio, we are currently looking forProject Quality and Risk Lead to be based in London with flexible working hours.

This position requires being at the at Clinical Unit (Northwick Park Hospital) initially 2/3 day per week as agreed with Line Manager.

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 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 point-of-contact for the client quality representatives for projects or accounts.

• Lead and facilitate the risk management process for assigned projects: Facilitate or lead project-level 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 on-site 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 real-time quality advice to enable project teams to deliver first-time quality. Consult SMEs including other quality experts when necessary to resolve. Review and investigate possible project-level SOP deviations as requested by project teams. Consult experienced PQRL or LM if needed

• Partner with project teams to achieve and maintain an inspection-ready state: Provide guidance on maintaining inspection-ready 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 inspection-readiness

• 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

• Develop and cultivate transparent quality relationships: Serve as the point-of-contact for the client quality representatives. Lead quality-to-quality meetings as needed. As Portfolio Quality & Risk Lead, perform client-level risk and issue management. As Portfolio Quality & Risk Lead, provide client-level quality oversight serving as a point of escalation, communicating pertinent information to account leadership as necessary. As Portfolio Quality & Risk Lead, develop/revise quality agreement as necessary

• Mentor new Project Quality and Risk Leads: Serve as an integration partner to facilitate induction to PQRM. Establish formal, documented plan for each new hire assigned.

Skills:

• Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.

• Developing analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.

• Ability to develop professional, collaborative relationships both internally and with the client.

• Developing skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues.

• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge.

• Ability to plan, organize, prioritize and manage workload with LM guidance, keeping the patient and client at the focus.

• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables.

• Developing the ability to manage the complexity of a matrix environment while valuing the importance of teamwork.

• Ability to travel 10% -15%