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Our ambition is to empower Integrated Informatics to deliver quality and compliance in an efficient way, right the first time.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs.

WHAT YOU’LL BE WORKING ON:

1. You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business.
2. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled.
3. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.
4. Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).
5. Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards.
6. Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements.
7. Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems.
8. Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution.
9. Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas.

STAKEHOLDER MANAGEMENT AND PARTNERING:

1. Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product.
2. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product.
3. Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes.
4. Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices.

IMPACT AND COMPLEXITY:

1. Define and manage product service levels, governance and operational support model aligned with stakeholder needs.
2. Lead or coordinate quality and compliance discussions.
3. Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations.
4. Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements.
5. Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.
6. Ensure information risk assessment process and implementation guidelines are followed.

What you’ll need to be successful:

1. Exhibits servant and creative leadership (VACC) behavior.
2. Exhibits a Lean-Agile Mindset and excels at Product Management practices.
3. Takes progressive risk--not thrill-seeking, but risk that leads to opportunity.
4. Has a keen Quality & Regulatory focus: You are passionate about major trends.
5. Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity.
6. Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.
7. Exhibits ability to empower teams and individuals to act autonomously and hold them accountable.
8. Exhibits intellectual curiosity and integrity and has a strong passion for innovation.
9. Understanding of health regulatory frameworks (FDA, GxP).
10. Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR).
11. Experience with control automation.

What you get:

1. Salary range 21 000 - 26 000 PLN gross based on the employment contract (Umowa o pracę).
2. Annual bonus payment based on your performance.
3. Dedicated training budget (training, certifications, conferences, diversified career paths etc.).
4. Highly flexible working arrangements - you have an impact on your daily schedule and you will work with your manager on how often you visit our office.
5. Recharge Fridays (2 Fridays off per quarter available).
6. Take time Program (up to 3 months of leave to use for any purpose).
7. Flex Location (possibility to perform our work from different places in the world for a certain period of time).
8. Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice).
9. Private healthcare (Medicover packages) and group life insurance (UNUM).
10. Stock share purchase additions.
11. Yearly sales of company laptops and cars and many more.

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Want to know what it’s like to be a part of Roche IT first-hand? Check out our blog!

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