Quality Assurance Manager CMOs **ID**:2323 **Date of Posting**:Feb 24, 2026 **Business Area**:Quality **Job Type**:Direct Employee **On site / Remote / Hybrid**:On Site **Hub Office**:Nanterre, FR **Territory**:
**Full-Time or Part-Time**:Tempo pieno **Seniority**:Executive
- With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn._
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- We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries._
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- At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves._
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- This drive will never stop. Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases._
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- Recordati. Unlocking the full potential of life._ **Job Purpose**
The CMO Quality Assurance Manager is responsible for ensuring robust quality oversight of all Contract Manufacturing Organizations (CMOs) engaged by Recordati Rare Diseases.The role ensures that outsourced manufacturing activities are conducted in full compliance with applicable Good Manufacturing Practices (GMP) and relevant national and international regulatory requirements.By supervising and supporting quality assurance activities related to Contract Manufacturing Organizations (CMOs),



this position contributes to maintain the highest standards of product quality, regulatory compliance, and patient safety.This position is open as part of a maternity leave replacement.**Key Responsibilities** **QA Operations & CMO Oversight**
- Ensure quality oversight of all CMO activities (manufacturing, packaging, testing).
- Implement governance processes and KPIs to monitor CMO performance.
- Ensure compliance with US FDA cGMP, EU-GMP, and internal quality standards.
- Conduct audits and inspections of CMOs and ensure follow‑up on findings.
- Develop, review, and maintain Quality Agreements with CMOs.
- Ensure proper documentation for all quality activities (batch records, validation, audits).
- Identify quality risks and implement mitigation actions.
- Provide training and guidance on quality standards to CMO teams.
- Drive continuous improvement of quality systems at CMOs.
- Work closely with internal teams (Regulatory Affairs, Supply Chain, Manufacturing).
- Manage change controls related to CMOs.
- Oversee Annual Product Quality Reviews (APQR) with CMOs.
- Participate in routine governance meetings and provide KPI reporting.
- Contribute to CMO evaluation and qualification. **QA Support to Projects**
- Support industrial technology transfer projects as the QA representative when required **Audits & Inspections**
- Participate in internal and external audits to assess GMP compliance.




- Communicate audit findings and support development of CAPAs.
- Maintain audit plans and ensure timely completion of corrective actions.
- Support preparation and management of regulatory inspections related to external manufacturing. **Optional QA Operations Suppor**t (When required)**
- Certify batches produced by CMOs.
- Review and approve deviations, CAPAs, and change controls.
- Follow up on CAPA closure with CMOs. **Required Education**
- Bachelor’s degree in Pharmacy from a recognized institution in France.
- Licensed French Pharmacist (mandatory). **Required Skills and Experience**
- Minimum 5 years of QA experience in the pharmaceutical industry, including CMO oversight
- Strong knowledge of US FDA cGMP and EU‑GMP regulations
- Solid analytical, problem‑solving, and communication skills
- Ability to work independently and collaboratively.
- Good understanding of pharmaceutical industry regulations and constraints
- Demonstrated leadership in a multicultural environment
- High autonomy in daily activitie
- QA certifications (e.g., ASQ CQA, CQM) are an advantage. **Technical Competencies**
- Minimum 5 years of experience in pharmaceutical Quality Assurance, including oversight of CMOs.
- Strong knowledge of US FDA cGMP and EU‑GMP regulations.
- Solid analytical, problem‑solving, and communication abilities.
- Proven capacity to work independently as well as collaboratively.
- Fluent French & English, written and spoken.
- Very good understanding of pharmaceutical regulations, industry standards, and operational constraints.
- Demonstrated leadership in multicultural environments.
- High level of autonomy in daily activities.
- Willingness to travel, including overnight stays.R

📌 Quality Assurance Manager Cmos (Provincia di Frosinone)
🏢 Recordati
📍 Provincia di Frosinone