Since 1929, ESTEVE has been driven by a clear and powerful purpose: improve people’s lives. Headquartered in Barcelona, we are a global pharmaceutical company with affiliates in Spain, Portugal, Italy, Germany, France, the UK, and the USA, as well as world-class production sites in Mexico and China supporting our global CMO business.

We are on an exciting growth journey, transforming into a leading international specialty pharma company, focused on highly specialized medicines that address unmet medical needs. At the heart of everything we do are our core values: people matter, transparency, and accountability.

We care, we do: Our commitment goes beyond medicine. We care about making a positive impact on people, the environment, and the way we do business.

We are looking for a Quality Manufacturing Senior Specialist to join the Quality & Compliance area of a leading pharmaceutical company.

This role plays a key part in guaranteeing GMP compliance across operations involving CMOs, suppliers and external manufacturing sites. Working closely with the Quality Pharma Manufacturing Manager and various internal and external stakeholders, this position ensures that quality standards, regulatory expectations and product safety requirements are consistently met.

The specialist will act as a trusted quality partner, supporting cross-functional projects, managing GMP documentation and providing expert oversight across activities related to injectable forms, validations, change control, deviations and quality investigations. The role also includes active participation in supplier and CMO qualification processes, stability protocols and global quality initiatives.

What we are looking for:
– Degree in Pharmacy or Sciences
– Solid experience in GMP environments, ideally with exposure to injectable products or sterile manufacturing
– Previous experience collaborating with CMOs, external manufacturing or pharmaceutical production
– Strong ability to manage projects, collaborate with multiple stakeholders and anticipate operational or regulatory risks
– Autonomous, analytical mindset and commitment to continuous improvement

Key Responsibilities:
– Provide oversight and management of Quality Assurance activities related to CMOs, suppliers and manufacturing sites to ensure GMP compliance
– Act as expert in process validation for injectable forms and manage Nitrosamines processes
– Review and approve GMP documentation including Batch Instructions, Test Specifications, Change Controls, Deviations, OOS/OOT records, Complaints, Validation Protocols and Reports, and related investigations
– Review and approve Stability Protocols and reports, ensuring alignment with operational and supply needs
– Implement Supplier / CMO / EP Manufacturing Sites quality monitoring processes based on risk assessment
– Participate in supplier and CMO lifecycle processes including selection, qualification and phase-out
– Provide guidance as Quality representative in new product initiatives to ensure regulatory and compliance alignment
– Manage assigned projects: coordination, planning and communication with stakeholders and senior management
– Act as gatekeeper in CMO qualification processes, including Quality Technical Agreement creation and review
– Monitor performance and drive improvements across CMOs and EP Manufacturing Sites
– Evaluate CMO and EP operations and recommend improvements to ensure compliance with quality and safety requirements
– Lead governance processes with CMOs and manufacturing sites, including KPIs, Quality Reviews and reporting
– Manage annual CMO / EP Manufacturing Sites Quality Reviews
– Implement improvement actions in manufacturing processes and track progress
– Lead or support GMP-related projects and continuous improvement initiatives
– Handle product complaints for local and international markets and ensure accurate reporting
– Identify trends and opportunities in quality matters for new project development
– Act as Quality Expert in global cross-functional teams (Regulatory Affairs, Sourcing, Global Projects, etc.)
– Maintain updated knowledge of GMP trends and provide training to global functions
– Support inspection readiness and collaborate with local teams during audits
– Manage Product Quality Reviews (PQRs) for CMOs and EP sites and ensure proper submission to commercial affiliates
– Ensure medicinal products marketed by the company meet regulatory requirements
– Act as Quality Lead during audits and commercial visits to CMOs and EP sites
– Support inspections from authorities and assist local quality teams

If you have experience in GMP environments, apply to the position. We would be delighted to get to know you.

Ready to join us on our purpose to improve people’s lives?  Become part of a team where your passion can make a real difference.