Manager, Clinical QA Program Lead

Manager, Clinical QA Program Lead

This position can be located in Raritan or Titusville, NJ, Horsham or Spring House, PA, Allschwil, Switzerland, Beerse, Belgium, High Wycombe, UK, and Madrid, Spain.

• Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits, ensuring connectivity and holistic alignment of strategies.
• Fosters the partnership between audit strategy and execution teams and enhances the value of Clinical audit programs through an enhanced audit report peer review process and the analysis and communications of meaningful audit outcomes.
• Monitors audit outcome trends and identifies proactive collaboration opportunities with stakeholders to resolve and address compliance-related matters and identify opportunities to enhance audit strategy and overall quality and compliance of clinical programs across therapeutic areas.
• Maintains and shares expert-level GCP knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
• Leverages data analytics tools to analyze relevant data sources and evaluates the data to identify any relevant trends and insights as input for the development of the appropriate audit program.

• Conducts GCP audits and supports GxP Audits as applicable (expected up to 50% time) with a focus on audits relevant to the responsible therapeutic areas.
• Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies, ensuring the relevant standard procedures, audit scopes and audit plans are fully understood and applied in audit activities.
• Independently leads and manages the domain-specific compliance audit programs as laid down in a comprehensive audit schedule, through planning, conducting and reporting of QA audits of activities, data, internal and external facilities and processes in GxP/non-regulated areas to assure adherence to company internal standards and policies/requirements, and compliance with applicable Health Authority regulatory requirements. This includes for cause, complex and business critical audits.
• Guides auditors in the scope definition, planning, conduct and reporting of audits, providing regulatory and process expertise within the applicable therapeutic area program(s).
• Prepares and reviews audit summary reports (or any materials) to share/escalate significant information with senior leaders.
• Proactively seeks solutions and contributes to the strategic direction for the execution of the audit plans, schedule and inspection-related activities, influencing the effective implementation of audit processes ensuring global alignment and harmonisation across domains and/or segments.
• Reviews risk profiles, provides expert input to risk management strategies and translates them into audit plans and audit scope for therapeutic area program(s).
• Provides expert support to auditors and business partners when developing and approving CAPAs, influencing consistency of CAPAs for similar issues, driving resolution of complex CAPAs and acting as a mediator between the different functions involved as needed.
• Conducts peer review of audit reports.

• Serves as the primary contact for applicable Clinical QA domain specific activities related to HA Inspections, including inspection readiness and coordinating with other functions as needed.

• Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company.
• Influences stakeholders and determines priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress and effectively drives projects to completion.

A minimum of a bachelor’s or equivalent University degree is required.

• Requires at least 5 years’ experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP-regulated discipline).
• Experienced in conducting GCP audits.
• Experienced in developing audit strategies and capabilities for applicable…