GxP Supplier Quality Manager

F. Hoffmann-La Roche AG; Madrid; In loco; EUR 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Roche Madrid seeks a GxP Supplier Quality Manager to ensure quality across external manufacturing and testing partners, engaging CMOs and CLOs to meet regulatory commitments.

You will oversee lifecycle activities, negotiate quality agreements, and drive risk management and continuous improvement, with travel up to 10%. A GMP/ISO/ICH background and English fluency are required.

Competenze

• Minimum 3–5 years in pharmaceutical/biotech quality roles.
• GxP supplier oversight experience with CMOs/CLOs preferred.
• Knowledge of cGMP, ISO, and ICH guidelines.

Mansioni

• Oversee quality activities across the full lifecycle of GxP suppliers.
• Develop, negotiate, and maintain Quality Agreements with suppliers.
• Collaborate with suppliers to address audit, CAPA, deviation and change control.
• Support Make Assess phase including master docs approvals and batch review.
• Ensure processes remain validated and compliant with regulatory dossiers.
• Develop and maintain QRM plans to mitigate supplier risks.
• Lead technical transfers and product launches at external sites.
• Drive continuous improvement and regulatory readiness with suppliers.

Conoscenze

English fluency

Critical thinking

Stakeholder management

Project management

Quality mindset

Formazione

B.A./B.S. in Life Sciences, Chemistry, Pharmacy, Engineering, or related field

Strumenti

MS Office

QMS (Quality Management Systems)

Descrizione del lavoro

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche, where structure, innovation, and patient safety converge, we are committed to delivering high-quality healthcare solutions worldwide. As a GxP Supplier Quality Manager, you will play a pivotal role in maintaining the integrity of our global supply chain across the entire lifecycle of GxP suppliers (Source & Select, Implement, Manage, and Decommission). You will serve as a primary quality key contact for Contract Manufacturing Organizations (CMOs), and Contract Laboratory Organizations (CLOs), ensuring that external partnerships align with Roche's high quality standards and regulatory commitments.

Key Responsibilities & Main Tasks

• GxP Supplier Lifecycle Management: Oversee all required quality activities across the full lifecycle of assigned GxP suppliers (Source & Select, Implement, Manage, and Decommission), including process or method validations, Roche audits, Health Authority inspections, complex investigations, product complaints, and regulatory submissions.
• Quality Agreements: Develop, negotiate, and maintain Quality Agreements with GxP suppliers, Partners, Collaborators, and External Sponsors, ensuring continuous compliance with agreed terms and regulations.
• Supplier Collaboration & Escalation: Collaborate with GxP suppliers to address gaps in audit responsiveness, deviation reporting/management, CAPA implementation, complaint resolution, investigation closures, and change control timelines; escalatie quality or compliance risks appropriately.
• Support "Make Assess": Manage all required quality deliverables supporting the Make Assess phase of Roche products, including approval of master process documentation, batch documentation review, resolution of complex deviations, change assessment, and ongoing supplier quality performance monitoring.
• Validated State & Compliance Maintenance: Ensure manufacturing and QC processes (including Specifications, Analytical Methods, and stability testing programs) remain in a validated state and fully compliant with applicable regulatory dossiers.
• Quality Risk Management (QRM): Develop and maintain quality risk management plans using established QRM tools (e.g., FMEA, root cause analysis) to proactively identify, mitigate, and monitor supplier quality and compliance risks.
• Technical Transfers & Product Launches: Lead and execute quality deliverables supporting technical transfers for manufacturing, testing, packaging, and commercial product launches at external sites.
• Continuous Improvement & Operational Excellence: Engage in cross-functional continuous improvement initiatives to solve complex manufacturing or quality challenges while driving alignment between supplier operations and Roche strategic goals.
• Regulatory Landscape & Intelligence: Communicate updated regulatory requirements and Roche expectations to GxP suppliers, evaluating site quality systems for ongoing compliance.

Who You Are

You are a self-motivated Quality professional who thrives in a dynamic, matrixed environment. You bring strong critical thinking, proactive communication, and the ability to influence external partners while keeping patient safety at the center of every decision.

Qualifications & Experience

• Education: Ideally, a B.A. or B.S. degree in Life Sciences, Chemistry, Pharmacy, Engineering, or a related discipline (or equivalent combination of education and industry experience).
• Experience: Minimum of 3–5 years of progressive experience in the pharmaceutical or biotech industry in Quality Assurance, Quality Control, or Supplier Quality Management.
• GxP & Supplier Expertise: Demonstrated experience with GxP supplier oversight (e.g., CMOs, CLOs, direct material suppliers) and familiarity with different technology platforms/dosage forms is preferred.
• Regulatory Knowledge: Sound knowledge of cGMP, ISO standards, and international pharmaceutical regulations (e.g., FDA, EMA, ICH Q9/Q10/Q12).
• Influence & Stakeholder Management: Strong capability to interpret complex quality standards, drive accountability with external vendors without direct authority, and negotiate Quality Agreements.
• Technical Skills: Operational Excellence (Lean/Six Sigma) and Project Management experience are a plus.
• High proficiency in MS Office or Google Workspace applications (Excel, PowerPoint, Word, Project).
• Languages & Travel: Excellent written and verbal communication skills in English (fluency is required). Ability to travel domestically and/or internationally up to 10%.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together.

Roche is an Equal Opportunity Employer. We believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.