Quality Assurance Associate Manager, Pre-Clinical R&D

Vetoquinol USA, Inc.; États-Unis; Hybride; USD 110 000 - 150 000; Plein temps

Résumé du poste

Vetoquinol USA, Inc. is seeking a Quality Assurance professional to support the Scientific Division by ensuring GLP and GCP compliance across preclinical and clinical studies.

You will contribute to maintaining the QA system, draft SOPs, and oversee audits of study plans, data, and reports to support regulatory readiness. The role requires a Master’s degree in a scientific discipline or equivalent experience, with 5+ years in GLP/GCP auditing and strong proficiency in QA tools.

Qualifications

• Master’s degree in a scientific discipline, or equivalent industry experience.
• 8+ years of relative experience in a scientific field may substitute for the degree.
• Knowledge of GLP/GCP regulations and proficiency in auditing techniques.
• Proficiency with standard and specialized computer applications.
• Experience in (pre)clinical studies and GLP/GCP Quality Auditor role.

Responsabilités

• Contribute to the implementation and maintenance of the QA system for the Scientific Division.
• Provide QA oversight during preclinical & clinical studies and audits of study plans, data, and reports.
• Coordinate corrective actions (CAPAs) and ensure timely closure.
• Prepare audit reports and QA statements; participate in regulatory inspections and external audits.
• Collaborate across US/LATAM to harmonize R&D QA practices.

Connaissances

GLP/GCP auditing

Auditing techniques

Preclinical studies

Computer applications

Quality Assurance

Formation

Master's degree in a scientific discipline

Equivalent industry experience

Description du poste

Within the framework of the Group's Quality Policy, contribute to the implementation and maintenance of the Quality Management System within the Scientific Division to ensure that preclinical & clinical studies comply with relevant Good Practices standards (GLP & GCPs). Support global R&D work by providing relevant QA oversight for the activities by interpreting local and regional applicable regulatory standards. Also contribute to fostering an internal culture of Quality focused on continuous improvement.

MAIN RESPONSIBILITIES:

(The following list of key responsibilities is not exhaustive. Additional activities related to those described, or of a similar nature, may be assigned without changing the nature of the position.)

Quality Policy / Quality Management System / Continuous Improvement

• 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.

Study Compliance

• 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.

Audit Program

• 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.

Regulatory Inspections and External Audits

• 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 .

Regulatory Monitoring and Training

• 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.

Projects

• Participate in the Quality oversight of Scientific Division development projects
• May attend project meetings as QA representative, coordinating QA activities across standards.

Health & Safety

• Ensure personal safety and the safety of colleagues by following safety procedures and reporting any hazardous situations.

Representation

• Represent VETOQUINOL in relevant professional association committees
• Develop and maintain a network of subject matter experts to support Quality activities

KEY WORKING RELATIONSHIP (outside of direct reporting lines) :

• Collaborate with the Pharmaceutical Research & Development Department (RDP Manufacturing), the Preclinical and Clinical Department (PCC), Project Managers, US Product Development Team, Human Resources, Information Systems (IT), Quality representatives from subsidiaries, consultants, subcontractors, suppliers, and Regulatory Authorities.

Educational Requirements:

• 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

Skills/Knowledge (Required)

• 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

Additional Skills (Preferred):

• French speaking (professional proficiency)

Vetoquinol USA is an equal opportunity employer. We are committed to providing a workplace that is free from discrimination of any kind and that promotes diversity, inclusion, and fairness. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. Join us and be a part of a great place to work!