Senior Quality Manager

Senior Quality Manager

Department Data Services, Project Quality and Risk Management (DS PQRM)

• Reports to Management within DS PQRM

• Provides Work Direction to (Senior) Quality Specialists, DS PQRM staff as assigned

• Works Closely with DS PQRM staff and Line Managers, Functional Leads, GDO Management, Training Business Partners, Process Subject Matter Experts (SMEs) and other Quality departments (e.g. LP PQRM, QA)

• External Relationships Sponsor, Sponsor Audit Teams, Regulatory Agency Inspectors, Industry Associations, Vendors

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.

Key Accountabilities:

Manage the relationship with Operations

• Collaborate with Leadership to 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 compliance

• Deputize for the Head of DS PQRM as assigned, representing a range of topics

• Provide transparency to compliance with quality expectations (and defining those expectations) to Operational management (e.g. via metrics, reports, meetings attended / chaired)

• Represent DS PQRM at management meetings both within Parexel Quality, Operations and externally where assigned

• Promote / champion the Quality Management System within both the group and the Operational teams via Operational management

• Provide input to or co-Chair assigned Quality Forums to facilitate meaningful discussion that leads to action on key risk areas

• Provide input to the Quality Review Board, to facilitate meaningful discussion that leads to action on key risk areas

• Propose, lead and implement PQRM initiatives to accomplish PQRM’s goals

• Perform other Quality related tasks as assigned

• Serve as an SME for varied PQRM activities

• Support development and implementation of strategy

• Perform Quality related activity as part of the wider DS PQRM group

Independently provide Quality input to audits/inspections

• Support 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 the most complex issues and root causes

• Facilitate development of robust CAPA for more complex issues

• Review audit/inspection responses prior to final QA review if necessary

• Contribute to critical issue resolution by providing expert quality advice and direction

Serve as an eQMS SME

Independently provide quality advice as assigned

• Respond to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements and input of appropriate SMEs, to enable project teams to deliver first-time quality

• 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, including on complex issues

• Act as SME on functional topics and Quality expectations, ensuring adequate input to SOP creation / revision

• Act as an experienced consultant to operations on the QMS and applicable regulationsQualificationsBachelor’s Degree or other relevant experience required; Masters preferred. Life-science, health

or industry-related discipline preferred.