GxP Supplier Quality Manager

About the role

Roche is looking for a GxP Supplier Quality Manager in Madrid. You will maintain the integrity of the global supply chain across the full lifecycle of GxP suppliers (Source & Select, Implement, Manage and Decommission) and act as the primary quality key contact for Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs), ensuring external partners meet Roche's quality and regulatory standards.

Key responsibilities

• Oversee quality activities for assigned GxP suppliers, including validations, Roche audits, Health Authority inspections, investigations, complaints, regulatory submissions and decommissioning.
• Develop, negotiate and maintain Quality Agreements with suppliers, partners, collaborators and external sponsors.
• Work with suppliers on audit responsiveness, deviation reporting, CAPA, complaint resolution, investigation closures and change control, escalating quality or compliance risks.
• Manage quality deliverables for the Make Assess phase, including master process documentation approval, batch documentation review, complex deviations, change assessment and supplier quality performance monitoring.
• Keep manufacturing and QC processes (Specifications, analytical methods, stability testing) validated and compliant with regulatory dossiers.
• Maintain quality risk management plans using tools such as FMEA and root cause analysis.
• Lead quality deliverables for technical transfers and product launches at external sites.
• Drive continuous improvement and communicate regulatory requirements and Roche expectations to suppliers.

Required profile

• Ideally a B.A. or B.S. in Life Sciences, Chemistry, Pharmacy, Engineering or a related field, or equivalent education and experience.
• Minimum 3-5 years of progressive experience in pharmaceutical or biotech Quality Assurance, Quality Control or Supplier Quality Management.
• Demonstrated experience with GxP supplier oversight (CMOs, CLOs, direct material suppliers); familiarity with technology platforms and dosage forms preferred.
• Sound knowledge of cGMP, ISO standards and international regulations (FDA, EMA, ICH Q9/Q10/Q12).
• Ability to influence external vendors without direct authority and negotiate Quality Agreements.
• Fluent English, written and spoken; domestic and international travel up to 10%.

Required skills

• Lean/Six Sigma and project management experience is a plus.
• High proficiency in MS Office or Google Workspace (Excel, PowerPoint, Word, Project).