Quality Manager

Job Description

Manage The Relationship With Operations Establish and maintain strong partnerships with Operational management assigned partners (likely at Director levels), other Quality and business functions (e.g., Risk Management, Project Quality & Risk Leads) and with Line Manager to ensure continuous improvement and regulatory complianceDeputize for the Head of the PQRM group as assigned, representing specific topicsProvide transparency to compliance with quality expectations (and defining those expectations) to Operational management (e.g., via metrics, reports, meetings attended / chaired)Represent Data Services PQRM at management meetings both within Parexel Quality, Operations and externally where assignedPromote / 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 areasPropose, lead and implement PQRM initiatives to accomplish PQRM’s goalsSupport development and implementation of strategyPerform other Quality related tasks as assigned Independently Provide Quality Input To Audits/inspections Support audit/inspection preparation including helping team set priorities and reviewing key documentsProvide onsite (office) or remote support as neededLead project team to investigate more complex issues and root causesFacilitate development of robust CAPA for more complex issuesReview audit/inspection responses prior to final QA review if necessaryContribute to critical issue resolution by providing expert quality advice and directionServe as an eQMS SME Independently provide quality advice as assigned 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 direction and take initiative in sharing relevant information. Translate for Parexel’s useProvide 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 innovationsEscalate issues to Leadership as necessary 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 on more complex QIs in;Supporting initial assessment of Serious Breach of GCPdeveloping 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 methodologiesServe as an eQMS SMEEscalate issues to Leadership as necessary Independently develop and cultivate transparent quality relationship on assigned Partnerships, to achieve and maintain inspection-ready performance: Maintain understanding of Parexel SOPs and Partnership expectations - and how they interactProvide consultancy, to ensure efficiency and regulatory compliance of proposed approaches when not following Parexel standardsSharing of Quality information and analyses, 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 Independently facilitate the Risk Evaluation process Work with Quality and Operational management to identify risk areasDevelop plans for the team to investigate specific process or account risksSupport/ lead complete assigned Risk Evaluations including; identifying relevant questions & identifying project types to use during the assessment, ensuring Operational Leadership buy-in to the approach and the questions, supporting others performing evaluation, discussing the results, defining suggested actions and providing input to a presentation of the resultsConfirm agreed mitigations have been integrated into departmental plansEncourage documenting lessons learnedAssess effectiveness of mitigations with management Maintain compliance with Parexel standards and regulatory requirements Comply with required training curriculaTake part in personal goal setting and performance review activitiesAccurately complete timesheet as requiredSubmit expense reports as required by SOPUpdate CVs and sign JD as required by SOP