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Senior Quality Manager
Parexel International Corporation
India - Any Region - Home Based
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.
Job posted: 2021-07-20