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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Senior Quality Manager

Job ID 70678BR 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 regulations

Qualifications

Bachelor’s Degree or other relevant experience required; Masters preferred. Life-science, health
or industry-related discipline preferred.

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