Head of Compliance and Quality Governance

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Head of Compliance and Quality Governance

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 platformssupporting both GxP and non-GxP critical business processesoperate 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 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.

The Opportunity

• 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 teams budget and resources developing detailed business casesincluding cost-benefit analyses and resource estimatesfor new functional initiatives and significant process changes.

Who You Are

• 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.

What you get:

• Salary range 30 300 - 56 300 PLN gross based on the employment contract.

• Annual bonus payment based on your performance.

• Dedicated training budget (training certifications conferences diversified career paths etc.).

• Recharge Fridays (2 Fridays off per quarter available).

• Take time Program (up to 3 months of leave to use for any purpose).

• Vacation subsidy available.

• Flex Location (possibility to perform our work from different places in the world for a certain period of time).

• Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice).

• Private healthcare (LuxMed packages) group life insurance (UNUM) and Multisport.

• Stock share purchase additions.

• Yearly sales of company laptops and cars and many more!

Apply directly and join us in shaping the future of healthcare.

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Polska sp. z o.o. operates in full compliance with the law and does not tolerate any violations. Roche Polska sp. z o.o. has implemented a Procedure for Reporting Violations of Law. If you wish to report any irregularities related to our activities all necessary information regarding the reporting process can be found on our website: & BenefitsThe expected salary range for this position based on the primary location of Warsaw Grafit is 364000.00 PLN - 676000.00 PLN. Final compensation will be determined by a number of factors including your skills experience qualifications and addition to base pay this role may be eligible for a discretionary annual bonus with a target of 20% subject to both individual and company performance.

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 100000 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.

Lets build a healthier future together.