Job Overview

Responsible for leading all day-to-day quality assurance and regulatory affairs operations at the PathQuest Paris site. Serves as the Site Head of Quality, overseeing the site quality organization, managing site quality personnel, and ensuring the site Quality Management System (QMS) is compliant with applicable GMP requirements and Charles River global quality standards. Guarantees the conformity of the site’s products and services with applicable regulatory requirements and ensures the filing and follow-up of regulatory dossiers with competent health authorities. Partners with the Global Head of Quality & Regulatory Affairs, BTS to align site quality and regulatory activities with global BTS quality strategy. Note: The individual in this role is also expected to concurrently hold the Pharmacien Responsable / QP social mandate, which is governed by a separate job description.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Site Quality Leadership
•    Lead and manage the PathQuest Paris site quality organization; directly manage all site quality personnel including performance management, development, coaching, and mentorship.
•    Responsible for all personnel management activities including scheduling, personnel actions, hiring, training and development, performance reviews, and disciplinary actions as applicable.
•    Establish, maintain, and continuously improve the site Quality Management System (QMS) in alignment with applicable GMP requirements (EU GMP Chapter 2, Annex 11, Annex 16, 21 CFR Part 11, ICH Q10) and Charles River global quality standards.
•    Develop and maintain all required SOPs, documents, forms, and quality documentation required to support site operations.
•    Oversee site deviation management, CAPA programs, change control, and internal audit activities.
•    Communicate all identified quality and compliance risks to the Global Head of Quality & Regulatory Affairs, BTS.

Regulatory Affairs
•    Define and implement the regulatory strategy for PathQuest Paris in alignment with the company’s pharmaceutical, commercial, and R&D policies.
•    Manage the filing and lifecycle maintenance of regulatory dossiers with competent health authorities, including BLA, DMF, SMF, BMF, IND, and IMPD submissions.
•    Respond to requests from regulatory authorities via sponsor organizations, including CMC technical documents, supplemental information, and method validation strategy documentation.
•    Manage change actions related to the Site Master File (SMF) and ensure timely updates across the regulatory dossier portfolio.
•    Lead regulatory strategy for BMF/SMF submissions for GMP tests and services offered by the site.

Client and Stakeholder Engagement
•    Serve as the primary quality and regulatory interface with clients, health authorities, suppliers, and subcontractors at the PathQuest Paris site.
•    Given the size and specialized nature of the PathQuest Paris site, this is a hands-on leadership role. The Associate Director is expected to be actively involved in day-to-day quality operations in addition to strategic and program-level responsibilities.
•    Performs all other related duties as assigned.

Qualifications

QUALIFICATIONS:
•    Education: Advanced scientific degree (Master’s or PhD/PharmD) in a relevant discipline. A European pharmacy diploma or recognized equivalent is strongly preferred given the concurrent Pharmacien Responsable mandate.
•    Experience: Minimum of five years of experience in quality assurance and/or regulatory affairs within the pharmaceutical or biotechnology industry, with a minimum of three years in a site quality leadership or managerial capacity.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    The individual in this role is expected to concurrently hold the Pharmacien Responsable / QP social mandate. Eligibility for CNOP registration (Section B, Ordre des Pharmaciens) is therefore a prerequisite.
•    Strong quality and regulatory expertise relevant to pharmaceutical activities, including EU GMP (21 CFR Part 11, Annex 11), ANSM regulations, and applicable international frameworks (FDA, EMA, ICH).
•    Expertise in biotechnology and/or Advanced Therapy Medicinal Products (ATMPs/MTI) is strongly preferred.
•    Experience in a contract research organization (CRO) or CDMO providing GMP biological testing services is preferred.
•    Demonstrated experience managing regulatory dossiers including SMF, BMF, BLA, DMF, IND, and IMPD throughout the product/service lifecycle.