Quality & Compliance Specialist

Roche

As a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.

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Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

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

You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g. CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).

Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards.

Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements

Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems.

Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution

Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

STAKEHOLDER MANAGEMENT AND PARTNERING:

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. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product.

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

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

Coordinate, connect and collaborate across informatics to foster a spirit of "One Roche"

IMPACT AND COMPLEXITY

Define and manage product service levels, governance and operational support model aligned with stakeholder needs

Lead or coordinate quality and compliance discussions

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

Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements

Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.

Ensure information risk assessment process and implementation guidelines are followed

What you’ll need to be successful

Exhibits servant and creative leadership (VACC) behavior

Exhibits a Lean-Agile Mindset and excels at Product Management practices

Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity

Has a keen Quality & Regulatory focus: You are passionate about major trends

Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

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.

Exhibits ability to empower teams and individuals to act autonomously and hold them accountable

Exhibits intellectual curiosity and integrity and has a strong passion for innovation

Understanding of health regulatory frameworks (FDA, GxP)

Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR)

Experience with control automation

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The Roche Services & Solutions as well as People Support Solutions organisations located in Kuala Lumpur provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the APAC region. Today Roche employs altogether around 1100 employees in Malaysia.

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