Associate Director, Quality and Regulatory Compliance

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

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.

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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