Cmo Qa Manager

Cpl Life Sciences; Lazio; Ibrido; EUR 120.000 - 160.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work

Espansione internazionale

Travel internazionale

Descrizione del lavoro

Cpl Life Sciences cerca un CMO QA Manager per guidare la supervisione di qualità a livello globale su CMOs e partner esterni. Ruolo internazionale con focus su GMP, audit, CAPA e insieme al management delle forniture.”

La posizione è ibrida, con possibilità di base a Madrid o Milano, richiedendo esperienza in ambienti GMP e un solido network con enti regolatori internazionali. Sarai parte di una funzione qualità globale e collaborerai con team internazionali.

Competenze

• Esperienza significativa in quality assurance GMP e manufacturing partner esterni.
• Capacità di gestire audit e ispezioni regolatorie (FDA/EMA/MHRA).
• Conoscenza sistemi di qualità, deviazioni, CAPA, change controls e investigations.
• Abilità nel gestire rischi secondo principi ICH Q9 e nello sviluppo di azioni correttive.
• Abilità nel guidare trasferimenti tecnologici, validazioni e PPQ.

Mansioni

• Fornire supervisione qualità per CMOs partner esterni.
• Guidare audit GMP su fornitori, CMOs e service providers.
• Supervisionare sistemi di qualità: deviazioni, CAPAs, change controls e investigations.
• Effettuare valutazioni del rischio e mitigazioni secondo ICH Q9.
• Revisionare e approvare indagini critiche e implementazioni CAPA sostenibili.
• Supportare ispezioni normative e interazioni con agenzie (FDA, EMA, MHRA).
• Fornire leadership di qualità per trasferimenti tecnologici, validazione e PPQ.
• Guidare qualificazione fornitori e monitoraggio delle prestazioni.
• Monitorare metriche qualità e trend di conformità.

Conoscenze

Quality Assurance

GMP Knowledge

Audit Management

Regulatory Inspections

Risk Management

Stakeholder Management

Communication Skills

Descrizione del lavoro

Descrizione dell'offerta di lavoro

Job Title: CMO QA Manager Job Type: Full time permanent Role Location: Madrid, Spain or Milan, Italy - Hybrid Remuneration: Competitive salary and benefits Cpl Life Sciences is partnering with a leading international pharmaceutical organisation to recruit a CMO QA Manager.

Continui a leggere per scoprire di cosa avrà bisogno per avere successo in questa posizione, incluse competenze, qualifiche ed esperienza.

This is an exciting opportunity for an experienced quality professional to take ownership of quality oversight activities across a global network of Contract Manufacturing Organisations (CMOs) and external partners.

Working within a highly visible international quality function, you will play a key role in ensuring GMP compliance, driving quality excellence, and supporting the delivery of safe, high-quality products to patients worldwide.

Key Responsibilities

• Provide quality oversight for assigned CMOs and external manufacturing partners.
• Lead and support GMP audits across contract manufacturers, suppliers, and service providers.
• Oversee quality systems activities including deviations, CAPAs, change controls, and investigations.
• Conduct quality risk assessments and drive effective risk mitigation strategies in line with ICH Q9 principles.
• Review and approve critical investigations, ensuring robust root cause analysis and sustainable CAPA implementation.
• Support regulatory inspection readiness and interactions with agencies including FDA, EMA, and MHRA.
• Provide quality leadership for technology transfers, process validation, PPQ, and new product introductions.
• Lead supplier qualification and ongoing quality performance management activities.
• Monitor quality metrics and compliance trends to identify and address emerging risks.
• Support quality governance forums and collaborate with cross-functional stakeholders to drive continuous improvement initiatives.

Candidate Profile

• Significant experience within pharmaceutical quality assurance and GMP-regulated manufacturing environments.
• Proven experience supporting external manufacturing operations, supplier quality, or CMO oversight activities.
• Strong understanding of GMP requirements, quality systems, investigations, CAPAs, and risk management methodologies.
• Experience supporting regulatory inspections and audit programmes.
• Ability to influence stakeholders and build strong relationships across internal and external partner networks.
• Excellent communication, problem-solving, and decision-making skills.
• Highly Desirable Experience within sterile manufacturing, aseptic processing, biologics, or Annex 1 environments.
• Expertise in sterility assurance, contamination control strategies (CCS), and data integrity.
• Experience supporting technology transfers, product launches, validation, and complex supply chains.

What's on Offer?

• Opportunity to join a growing global pharmaceutical organisation.
• High-profile role with significant exposure to senior stakeholders and external manufacturing partners.
• International scope with opportunities to influence quality strategy and culture.
• Hybrid working arrangement based in either Madrid or Milan.
• International travel opportunities as part of a global quality leadership function.

Please note you must be located in the 1 of location share in the location. xysqume