Quality Specialist I

Assist 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 compliance • Provide transparency to compliance with quality expectations (and assist with 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 management • If requested provide input to Quality Forums, to facilitate meaningful discussion that leads to action on key risk areas • Contribute to initiatives to accomplish PQRM’s goals • Perform other Quality related tasks as assigned

Assist in providing Quality input to audits/inspections with Line Manager or experienced PQRM assistance

• Assist in supporting audit/inspection preparation including helping team set priorities and reviewing key documents • Provide onsite (office) or remote support as needed • Lead project team to investigate root causes • Facilitate development of robust CAPA • Review audit/inspection responses prior to final QA review if necessary • Contribute 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 firsttime quality • Review and propose SOP deviations using ICH-GCP, Parexel processes, regulatory requirements • Consult SMEs including other quality experts when necessary to resolve issues • Review and investigate possible SOP deviations as requested • Represent Parexel Quality at client or internal meetings • Act as SME on functional topics and Quality expectations, ensuring adequate input to SOP creation / revision • Act as a consultant to operations on the QMS and applicable regulations • Identify continuous improvement opportunities, facilitate the development of recommendations and champion implementation • Maintain industry awareness including future technology, business, Quality and regulatory direction • 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

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 assigned • 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) • assessing effectiveness of CAPA as necessary with QI team and action owners • Use 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 standards • Sharing 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 needed • Audit/inspection support: Represent Parexel Quality and ensure the partnership /project team are prepared for audit, supported throughout and reviewing audit responses

Facilitate the Risk Evaluation process

• Work with Quality and Operational management to identify risk areas • Complete 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

• Comply with required training curricula • Take part in personal goal setting and performance review activities • Accurately complete timesheet as required • Submit expense reports as required by SOP • Update CVs and sign JD as required by SOP • Comply with Parexel processes, ICH-GCPs and other applicable requirements