Job Purpose

The Quality Assurance Manager for the Nanterre Plant ensures the effective operation, compliance, and continuous improvement of RRD's Quality Management System. Reporting to the Senior Director of Quality Assurance Operations, the role safeguards adherence to all applicable quality standards, including the French Public Health Code, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), internal Standard Operating Procedures (SOPs), and regulatory requirements.
The position leads and coordinates all Quality Assurance activities for the Nanterre site and oversees the daily management of the QA team to achieve operational objectives and support a culture of quality excellence.

Key Responsibilities

Quality System Leadership & Compliance

• Design, implement, and maintain the Quality Management System aligned with RECORDATI Group standards.
• Ensure compliance with GMP, GDP, GxP, the French Public Health Code, marketing authorizations (MA), and all applicable regulations.
• Develop, review, and implement Standard Operating Procedures (SOPs) and ensure complete documentation control.
• Coordinate validation, qualification, and calibration strategies.
• Implement Data Integrity requirements across the site.

Operational Quality Management

• Oversee timely release of bulk materials, packaging components, and finished product batches.
• Ensure that products are manufactured, packaged, and distributed according to defined procedures and regulatory expectations.
• Support production and logistics teams on quality projects and continuous improvement initiatives.
• Manage complaint investigations, product recalls, and quality-related risks.

Audit, Inspection & Regulatory Interface

• Define and manage internal and external audit programs, including supplier and partner audits.
• Conduct audits independently or with the Delegated Qualified Person (QP) or Quality Pharmacist.
• Prepare for and host inspections from regulatory authorities (e.g., ANSM, EMA, FDA, Health Canada).
• Prepare responses to inspection reports and ensure timely execution of corrective actions.
• Support maintenance of the Nanterre site manufacturing license.

Team Leadership & Training

• Manage the daily activities of the Quality Assurance team.
• Allocate resources, set priorities, and validate action plans following deviations, failures, and complaints.
• Develop training material and ensure periodic GMP training for relevant staff.
• Promote a strong quality culture and operational excellence mindset.

Documentation & Reporting

• Ensure accurate, up-to-date documentation (SOPs, work instructions, forms).
• Manage Product Quality Reviews (PQR) for Nanterre activities.
• Prepare the annual Site Master Plan ("État des Lieux").
• Define and monitor Quality KPIs; report results to Headquarters.
• Coordinate quality agreements with manufacturers, suppliers, wholesalers, and distributors.

Risk Management & Continuous Improvement

• Lead risk evaluation, mitigation strategies, and cross-functional alignment (Production, Logistics, etc.).
• Identify quality challenges and implement short-, medium-, and long-term solutions.
• Support operational excellence initiatives and continuous improvement programs.

Required Education

• Diploma of doctor of pharmacy
• Mandatory registration with the order of pharmacists in France
• Significant experience of at least 15 years as a Quality Manager

Required Skills and Experience

• Degree in Pharmacy, Life Sciences, Engineering, or related field.
• Solid experience in Quality Assurance within the pharmaceutical or healthcare industry.
• Strong knowledge of GMP, GDP, and the French Public Health Code.
• Experience managing audits, inspections, and regulatory interactions.
• Proven managerial and team-leadership skills.

Technical Competencies

• Strong computer literacy, including proficiency with the Microsoft Office Suite (Word, Excel, PowerPoint).
• Expertise in key Quality & Compliance IT systems, including VEEVA (QMS/Docs), LMS SuccessFactors (training), and S/4HANA (ERP).

Required Behaviours and Competencies

Required Behaviours

• Strong compliance mindset, demonstrating consistent respect for procedures, standards, and regulatory requirements.
• High level of initiative and self-motivation, with the ability to drive tasks and improvements proactively.
• Flexible, positive, and enthusiastic attitude, adaptable to evolving priorities and operational changes.
• Strong interpersonal skills and pedagogy, supporting effective collaboration and successful training of others.
• Ability to work effectively in multicultural environments with clear and respectful communication across diverse teams.
• Sound conflict-resolution abilities, maintaining professionalism in challenging or tense situations.
• Strong decision-making capabilities, especially in regulated, time-sensitive or high-impact environments.

Required Competencies

• Excellent organizational skills with the ability to manage time, priorities, and deadlines efficiently.
• Demonstrated leadership abilities, including team motivation, performance management, and the ability to enforce expectations when necessary.
• Strong knowledge of pharmaceutical quality control, including GMP/GDP requirements and drug quality standards.
• Ability to manage multiple tasks and projects simultaneously in a structured and efficient manner.

Required Languages

• Technical writing skills in French and English
• Excellent English & French spoken

Travel required in %

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.