[Remote] Quality Assurance Associate Manager, Pre-Clinical R&D

Note: The job is a remote job and is open to candidates in USA. Vetoquinol USA is seeking a Quality Assurance Associate Manager to support the implementation and maintenance of the R&D Quality Management System. The role provides QA oversight for preclinical and clinical studies, audits, regulatory inspections, and continuous improvement to help ensure compliance with GLP/GCP and applicable regulations.

Responsibilities

• Contribute to the implementation of the Quality Policy and participate in the development, maintenance, and continuous improvement of the R&D Quality Management System, with a focus on simplification and efficiency
• Draft Quality Department documentation, including Quality Action Plans and Standard Operating Procedures (SOPs)
• Review Scientific Division documents, ensuring compliance and advising operational departments where necessary (e.g., GLP/GCP assessments, procedures)
• Ensure the proper implementation of Quality processes and manage deviations and Corrective and Preventive Actions (CAPAs)
• Establish performance indicators relevant to Quality activities, prepare trend analyses, and present them during Management Reviews
• Provide Quality Assurance (QA) support throughout the conduct of preclinical studies
• Assess compliance with Good Laboratory Practice (GLP – 21CFR Part 58) or Good Clinical Practices (GCP) and applicable SOPs by auditing study plans/protocols, amendments, critical study phases, raw data, and study reports – including activities subcontracted to CROs when applicable
• Prepare audit reports, verify the implementation of corrective actions, and sign Quality Assurance statements
• Organize QA activities according to the audit schedule established with the Preclinical and Clinical Departments and coordinate outsourced document audits
• Participate in the management of subcontractors involved in R&D activities for business areas located in the Americas (US BA and LATAM-C BA)
• Develop internal and external audit programs based on risk assessment and the project portfolio to ensure compliance with GLP/GCP and internal procedures
• Conduct or outsource audits according to established priorities
• Document all audits (preparatory documents and audit reports) propose corrective actions where appropriate, and distribute audit reports to the relevant personnel
• Ensure the appropriate corrective measures are implemented to address identified deviations and non-conformities
• Serve as the Quality Assurance representative during inspections and communications with regulatory authorities associated with R&D work
• Coordinate the preparation of responses to inspection with the relevant department and monitor the implementation of corrective actions within the agreed timelines
• Monitor regulatory development and contribute to the interpretation of regulations related to GLP/GCP and other regulations impacting R&D work in the area under responsibility
• Raise awareness and provide training to personnel involved in R&D work
• May act as mentor for new members of the Quality Department and act as liaison officer to ensure harmonization of practices between Europe and US for activities operated in compliance with the R&D Quality Management System
• Participate in the Quality oversight of Scientific Division development projects
• May attend project meetings as QA representative, coordinating QA activities across standards
• Ensure personal safety and the safety of colleagues by following safety procedures and reporting any hazardous situations
• Represent VETOQUINOL in relevant professional association committees
• Develop and maintain a network of subject matter experts to support Quality activities

Skills

• Master's degree in a scientific discipline, or equivalent industry experience
• 8+ years of relative experience in a scientific equivalent may be substituted for educational requirements
• Knowledge of GLP/GCP regulations and proficiency in auditing techniques
• Technical Knowledge on execution of (pre)clinical studies
• Minimum 5 years' experience as a GLP or GCP Quality Auditor
• Proficiency with standard and specialized computer applications
• Experience in animal health (pre)clinical studies
• French speaking (professional proficiency)

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