R&D Audit & Inspection Associate

Role Summary

The R&D Audit & Inspection Associate provides essential support, oversight, and education to quality and business personnel concerning various components of the quality system, with a primary focus on Audits and Inspections and Notification to Management (NTM). This role is critical in ensuring GMQO’s readiness for audits and inspections, enhancing quality system components, and supporting continuous improvement efforts with the GMQO Process Owner for Audits and Inspections.

Responsibilities

• Provides support, monitoring, and education to quality and business personnel for assigned quality system components, including, but not limited to Audits and Inspections, Notification to Management (NTM).
• Works closely with the GMQO process owner for Audits and Inspections for the monitoring and continuous improvement of the process.
• Serves as SharePoint Site Administrator (MIM sites) and supports the development and management of a cross functional inspection management infrastructure for logistics, preparation/planning, and close out activities including tracking all sponsor requests and facilitating inspection management response process.
• Administratively and logistically facilitates and manages backroom for sponsor inspections and audits hosted by Global Medicines Quality Organization.
• Manages the appropriate archiving of audits and inspections data and retrieval of documentation from various systems to support audits and inspections including master SOP list and documents in long-term storage or eArchive.
• Performs timely data entry as relates to audit / inspection conduct into Trackwise/Veeva and maintains, analyzes, and facilitates any actions as a result of bi-monthly inspection update metrics used by management and GMQO for inspection readiness.
• Coordinates routine and ad-hoc mock inspections / rehearsals in collaboration with GMQO.
• Maintains inspection readiness artifacts including but not limited to: Inspection Distribution List; Inspection Presentations; Inspection Organization Chart; Audit and Inspection Training.
• Participates in industry forums for inspection readiness information exchange and benchmarking as applicable.
• Lead, or conduct other projects /tasks as requested in the management of audit and inspection activities.
• Responsible for compiling and reporting of audit / inspection compliance metrics at appropriate levels for management review.
• Performs trend analysis on inspection and audit issues/observations to provide meaningful and actionable data at governance meetings and for use in ongoing inspection readiness.
• Participates in the preparation of annual audit and self-inspection plans in collaboration with management and GQAAC.
• Participates in Management Review preparations for audit and inspection data in collaboration with Standard owners and GQAAC.

Qualifications

• Required: Bachelor’s degree or High School Diploma and 10 years’ experience in the Pharmaceutical Industry
• Preferred: Experience in Inspection/Audit preparation of Sponsor and related sites (e.g., clinical sites) within a GCP/GLP/GPvP environment
• Preferred: Experience with IT/systems supporting quality; specifically, TrackWise, Notification to Management, SharePoint and Power BI
• Preferred: Knowledge of GLP, GCP and GVP global regulations as they relate to Clinical Development, Drug Safety and Drug Development
• Preferred: Excellent communication skills, both written and oral. Ability to effectively develop and present information to all levels of the organization
• Preferred: Prioritize and handle multiple concurrent tasks with good planning and organization skills
• Preferred: Ability to work across functions to obtain input, resolve differences, and achieve results
• Preferred: Apply sound judgment in a regulated environment
• Preferred: Ability to assess current state and implement improvements and action plans
• Preferred: Manage complex projects end-to-end, coordinate cross-functional teams, and keep deliverables on track
• Preferred: Strong communication skills to translate technical information into clear updates for diverse audiences
• Preferred: Track record of maintaining alignment across teams, anticipating risks, and resolving issues proactively
• Preferred: Risk-based mindset and ability to prioritize work using Risk Management methodologies
• Preferred: Team-based and independent collaboration with management at various levels
• Travel: Limited travel 0-10%
• Authorized to work in the United States on a full-time basis (no visa sponsorship provided)

Skills

• Communication (verbal and written) at all organizational levels
• Project management and cross-functional coordination
• Quality systems knowledge and regulatory awareness (GLP, GCP, GVP)
• Data analysis and metrics reporting
• Documentation control and audit readiness
• SharePoint administration and information management

Additional Requirements

• Limited travel: 0-10%
• Authorized to work in the United States on a full-time basis (no sponsorship)