Job Purpose

CMO QA Certification & Release acts as the Qualified Person (QP) Deputy, is responsible for the certification and timely release of medicinal product batches across the entire Recordati Rare Diseases (RRD) portfolio.

The role ensures that all batches released to the market fully comply with EU Good Manufacturing Practices (EU-GMP), Marketing Authorisations, the RRD Quality Management System, and the French Public Health Code.

In addition, the position is accountable for Master Data Governance within the SAP S/4HANA Quality Management (QM) module, ensuring the accuracy, completeness, and regulatory compliance of all quality‑relevant master data supporting batch certification and release activities.

Key Responsibilities

Batch Certification & Release
- Act as QP Deputy for the certification and release of medicinal product batches across the full RRD portfolio.
- Ensure timely release of finished products in compliance with business and regulatory timelines.
- Guarantee that all batches meet EU-GMP requirements, Marketing Authorisations, internal Quality Systems, and the French Public Health Code prior to release.
Batch Documentation Review & Compliance
- Review and approve batch documentation from manufacturing, packaging, and quality control activities.
- Assess all quality events impacting batches (deviations, complaints, CAPAs, and change controls) to ensure full compliance before release.
- Ensure completeness, accuracy, and availability of all documentation required for batch certification and release.
Quality Systems & Process Management
- Design, implement, and maintain Quality Systems related to batch certification and release in line with regulatory requirements and Recordati Quality standards.
- Ensure compliance with EU-GMP (including Annex 16), Marketing Authorisation dossiers, and applicable regulations.
- Define and monitor Quality Release KPIs to ensure performance, compliance, and continuous improvement.
Master Data Governance (SAP S/4HANA)
- Lead and oversee Master Data Governance activities within the SAP S/4HANA QM module.
- Ensure accuracy, completeness, and GMP compliance of all quality-relevant master data supporting batch release.
- Act as QA approver for changes related to Master Data and ensure alignment with regulatory and operational requirements.
External Partners & CMO Oversight
- Ensure appropriate QA oversight of CMOs, laboratories, and logistics partners involved in manufacturing and QC activities.
- Review and monitor quality events and CAPAs from CMOs, ensuring effectiveness and compliance.
- Oversee Product Quality Review (PQR) activities for outsourced products, including data collection, analysis, and reporting.
- Support maintenance and periodic review of Quality and Technical Agreements (QTAs).
Cross-functional Collaboration
- Collaborate closely with Global Supply Chain, Regulatory Affairs, Production, and external partners to ensure smooth batch release operations.
- Coordinate the collection and consolidation of all documentation required for release activities.
Continuous Improvement & Compliance Culture
- Identify opportunities to improve batch release processes and implement optimized tools and methodologies.
- Support the development and update of SOPs related to certification and release activities.
- Promote a strong GMP compliance culture and contribute to the continuous improvement of the Quality Management System.

Required Education

Diploma of doctor of pharmacy
Mandatory registration with the order of pharmacists in France

Required Skills and Experience

Qualified Pharmacist (PharmD) with mandatory registration with the French Order of Pharmacists.
Significant experience (minimum 3 years) as a QP Deputy in a GMP-regulated pharmaceutical environment.
Strong organizational and time management skills, with the ability to meet strict deadlines.
Ability to manage multiple priorities and make sound decisions.
Ability to work in cross-functional and multicultural environments.

Technical Competencies

GMP & Regulatory Expertise
Advanced knowledge of EU Good Manufacturing Practices (EU-GMP), including Annex 16 requirements for batch certification and release, as well as regulatory frameworks such as Marketing Authorisations and the French Public Health Code.

Batch Certification & Release
Strong expertise in batch record review, certification, and release processes, ensuring full compliance with quality and regulatory requirements.

Quality Systems Management
Solid experience with Quality Management Systems (QMS), including handling of deviations, CAPAs, complaints, and change controls impacting product quality and release.

CMO & External Manufacturing Oversight
Proven ability to oversee Contract Manufacturing Organizations (CMOs), laboratories, and external partners, ensuring compliance with GMP and Quality Agreements.

Master Data Governance (SAP S/4HANA QM)
Expertise in managing and governing quality-related master data within SAP S/4HANA (QM module), ensuring data accuracy, integrity, and compliance.

Documentation Review & Compliance Control
Ability to review and approve batch documentation, ensuring completeness, traceability, and alignment with regulatory and internal standards.

Product Quality Review (PQR)
Experience in managing PQR processes, including data collection, analysis, reporting, and ensuring compliance with GMP requirements.

Quality Agreements Management
Knowledge of drafting, reviewing, and maintaining Quality and Technical Agreements (QTAs) with external partners.

Data Integrity & IT Systems
Strong understanding of data integrity principles and proficiency in relevant IT systems (SAP S/4HANA, Veeva, LMS, Office tools).

Process Improvement & KPI Monitoring
Ability to define, track, and analyze quality KPIs, and implement continuous improvement initiatives to optimize batch release processes

Required Behaviours and Competencies

Leadership & Influence
Demonstrates leadership in a cross-functional environment and the ability to influence stakeholders and external partners.
Communication Skills
Strong verbal and written communication skills, with the ability to clearly present quality and regulatory topics.
Decision-Making & Judgement
Ability to make sound, timely decisions in a regulated environment, particularly regarding batch certification and release.
Organisation & Planning
Strong organizational and time management skills, with the ability to prioritize, manage multiple tasks, and meet deadlines.
Collaboration & Teamwork
Ability to work effectively with cross-functional teams and in multicultural environments.
Autonomy & Accountability
High level of ownership, initiative, and self-motivation in managing responsibilities.
Adaptability & Flexibility
Ability to adapt to changing priorities, regulatory environments, and business needs.
Continuous Improvement Mindset
Proactive approach to identifying improvements and enhancing quality systems and processes.

Required Languages

Excellent command of French and English (written and spoken)

Recordati

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