Quality Specialist II

Job Purpose: Partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients.

The Quality Specialist II will assist with establishing and maintaining a strong partnership with Operational management assigned partners, other Quality and business functions (e.g. Risk Management, Project Quality & Risk Leads) and with Line Manager to ensure continuous improvement and regulatory compliance. Provide input to Quality Forums, to facilitate meaningful discussion that leads to action on key risk areas. Support audit/inspection preparation including helping team set priorities and reviewing key documents. Respond to consultancy requests to enable project teams to deliver first-time quality. Review and approve SOP deviations using ICH-GCP, Parexel processes, regulatory requirements. Where assigned as QM Representative, assist QI Manager in; developing containment actions, facilitating QI team to investigate root causes, facilitating development of robust corrective and preventive actions (CAPA) and assessing effectiveness of CAPA as necessary with QI team and action owners using available tools and methodologies. Work with Quality and Operational management to identify risk areas. Complete assigned Risk Evaluations Manage the relationship with Operations, with Line Manager or experienced PQRM assistance Assist with establishing and maintaining a strong partnership with Operational management assigned partners, other Quality and business functions (e.g. Risk Management, Project Quality & Risk Leads) and with Line Manager to ensure continuous improvement and regulatory complianceProvide transparency to compliance with quality expectations (and defining those expectations) to Operational management (e.g. via metrics, reports, meetings attended / chaired)Promote / champion the Quality Management System within both the group and the Operational teams via Operational managementProvide input to Quality Forums, to facilitate meaningful discussion that leads to action on key risk areasContribute to initiatives to accomplish PQRM's goalsPerform other Quality related tasks as assigned Provide Quality input to audits/inspections with Line Manager or experienced PQRM assistance Support audit/inspection preparation including helping team set priorities and reviewing key documentsProvide onsite (office) or remote support as neededLead project team to investigate root causesFacilitate development of robust CAPAReview audit/inspection responses prior to final QA review if necessaryContribute to critical issue resolution by providing expert quality advice and direction Provide quality consultancy as assigned and with LM or experienced PQRM assistance Respond to consultancy requests to enable project teams to deliver first-time qualityReview and approve SOP deviations using ICH-GCP, Parexel processes, regulatory requirementsConsult SMEs including other quality experts when necessary to resolve issuesReview and investigate possible SOP deviations as requestedRepresent Parexel Quality at client or internal meetingsAct as SME on functional topics and Quality expectations, ensuring adequate input to SOP creation / revisionAct as a consultant to operations on the QMS and applicable regulationsIdentify continuous improvement opportunities, facilitate the development of recommendations and champion implementationMaintain industry awareness including future technology, business, Quality and regulatory directionProvide feedback via the appropriate channel when gaps or issues are identified with Parexel processesPropose ideas to PQRM leadership related to departmental efficiencies, potential improvements, or innovations Facilitate identification, investigation and remediation of Quality Issues (QIs) as assigned Ensure triage of relevant quality issues in electronic quality management system (eQMS) ensuring appropriate classification, as assignedWhere assigned as QM Representative, assist QI Manager in;developing containment actionsfacilitating QI team to investigate root causesfacilitating development of robust corrective and preventive actions (CAPA)assessing effectiveness of CAPA as necessary with QI team and action ownersUse available tools and methodologies Develop and cultivate transparent quality relationship on assigned Partnerships, to achieve and maintain inspection-ready performance, with Line Manager or experienced PQRM assistance Maintain understanding of Parexel SOPs and Partnership expectations - and how they interact Provide consultancy, to ensure efficiency and regulatory compliance of proposed approaches when not following Parexel standardsSharing of Quality information internally (e.g. QI reports)Be a consistent internal point of contact within Quality. Facilitate provision of support from the wider Parexel Quality organization / Quality Management System as neededAudit/inspection support: Represent Parexel Quality and ensure the partnership /project team are prepared for audit, supported throughout and reviewing audit responsesQuality Issue support: Be assigned as QM Representative on Partnership QIs Facilitate the Risk Evaluation process Work with Quality and Operational management to identify risk areasComplete assigned Risk Evaluations including; support with identifying relevant questions & identifying project types to use during the assessment, discussing the results, defining suggested actions and providing input to a presentation of the results Confirm agreed mitigations have been integrated into departmental plans•Encourage documenting lessons learned Maintain compliance with Parexel standards and regulatory requirements Skills:
• Self-management: independent, takes initiative, proactive and organized
• Focused on quality results - attention to detail and First Time Quality
• Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
• Emerging skills as an analytical critical thinker, focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions
• 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
• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables
• Ability to manage the complexity of a matrix environment while valuing the importance of teamwork
• Cultural awareness with the ability to think and work, globally
• Ability to travel as needed for the position Knowledge and Experience:
• Knowledge of ICH-GCP and clinical trial regulation
• English proficiency (written and oral)
• Industry experience in one or more areas of PQRM support and / or Quality Management
• IT literate - experience with Microsoft based applications and functional and TMF applications / languages / solutions. Able to embrace new technology and apply best practices #LI-REMOTE

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