Head of Compliance and Quality Governance
Roche
Unknown, województwo mazowieckie, Polska
Full-Time
Competitive
HybridDirector
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.
Operating within an innovation-driven biotech environment, our Technology department (RDT) sits at the intersection of regulatory compliance, quality systems, risk management, and digital transformation. We focus on defining and managing governance frameworks, policies, and processes that ensure our technology platforms—supporting both GxP and non-GxP critical business processes—operate in full compliance with internal standards and external regulations. Our mission is to embed compliance by design, strengthening the quality and risk posture of our systems while simultaneously enabling speed, scalability, and technological innovation. In this collaborative environment, we partner closely with Business Quality, Regulatory, Security, Legal, and Audit functions to advise executives and drive enterprise-wide strategy.
As the Head of Compliance and Quality Governance (Practice Leader), you will be accountable for the entire lifecycle of this critical function, from strategic planning and service design to operational execution and continuous improvement. Operating as a senior escalation and decision authority, you will define the functional vision, strategy, and roadmap, transforming business needs into tangible, high-value capabilities. Leveraging a distinctive combination of deep domain expertise, technical proficiency, and business insight, you will lead multidisciplinary teams to build and deliver desirable, viable, and sustainable functional services that meet the evolving needs of our users while maintaining strict regulatory compliance.
Strategy & Vision: Define and own the Technology Compliance & Quality Governance strategy, establishing clear governance frameworks, decision models, and accountabilities while translating global biotech regulations and corporate policies into clear technology outcomes.
Stakeholder & Business Partnership: Serve as a trusted partner and senior escalation authority for executives, Quality, Regulatory Affairs, and Security leadership, representing Technology in executive forums, audits, inspections, and regulatory interactions.
Functional Management & Delivery: Oversee the end-to-end delivery and lifecycle of defined functions (e.g., QMS), ensuring Technology adherence to GxP, CSV, data integrity, privacy, and global regulations (FDA, EMA, ICH, ISO) through pragmatic, risk-based interpretations.
Risk Management & Assurance: Lead enterprise-wide technology risk assessments and compliance maturity evaluations, ensuring timely and effective remediation of findings, deviations, and CAPAs.
Team Leadership & Development: Build, coach, and develop a high-performing global team of professionals, fostering a culture of accountability and transparency while guiding senior leaders on risk-based decision-making.
Operational Excellence & Improvement: Define success metrics (KPIs/OKRs) and leverage data analytics to drive informed decisions, immediate operational improvements, and strategic optimizations to achieve business goals.
Financial & Resource Management: Manage the immediate team's budget and resources, developing detailed business cases—including cost-benefit analyses and resource estimates—for new functional initiatives and significant process changes.
Experienced Global Leader: You bring 15+ years of IT domain experience, including 10+ years managing global multidisciplinary teams and 10+ years in Technology, Compliance, Quality, or Risk within highly regulated industries (biotech, pharma, medical devices) at the senior leadership or executive level.
Regulatory & ITSM Expert: You possess deep expertise in Quality Management Systems, GxP, CSV, GDPR, regional health data regulations, and ISO standards (e.g., ISO 27001), alongside proven leadership in IT Service Management (ITSM) and its core governance processes (incident, problem, change, release, configuration, and continuity).
Modern Technology Strategist: You have extensive experience governing modern technology landscapes (cloud, digital platforms, data, AI/Automation, DevOps) in regulated environments, and familiarity with data science and AI/ML concepts in the compliance space is a major plus.
Risk & Value Balancer: You excel at managing and interpreting risks, deviations, and CAPAs, transforming insights into sustainable improvements, and successfully balancing operational excellence and regulatory compliance with the delivery of business value.
Influential Communicator & Mentor: You are adept at translating high-level business goals into concrete roadmaps, leading through influence and partnership rather than just control, and aligning diverse global stakeholders across complex engineering, business, and executive ecosystems.
Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!
This position also offers an attractive benefits package.
Learn more about how we reward our employees at Roche.
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.