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

Mission

As a GPC Compliance Assurance Specialist, you will be responsible for safeguarding the Global Patient Care (GPC) Organization by ensuring adherence to regulatory requirements, internal Standard Operating Procedures (SOPs), and safety protocols. Your mission is to move beyond service quality to a rigorous model of Compliance Monitoring across all customer channels.

You will act as a primary point of contact of GPC's Inspection Ready status. By managing audit schedules, maintaining critical documentation, and liaising with Global Post Market Quality and Local Safety Officers, you will ensure that customer interactions and processes meet the highest legal and medical regulatory standards. You will identify systemic risks and implement corrective actions to maintain the integrity of our patient care operations.

Key Accountabilities

Compliance Monitoring: Conduct regular, systematic compliance audits across all supported channels to ensure adherence to safety reporting and regulatory guidelines.
Documentation Management: Author, update, and maintain Standard Operating Procedures (SOPs) and relevant compliance documentation to reflect current global and local requirements.
Audit Management: Lead the preparation and management of the GPC audit schedule; coordinate all pre-work to ensure the organization is prepared for internal and external inspections.
Stakeholder Liaison: Act as the key point of contact for affiliate Local Safety Officers (LSOs) and Global Post Market Quality teams to align on safety reporting and quality standards.
Audit Participation: Actively participate in GPC-relevant audits, providing evidence, responding to inquiries, and managing the documentation trail.
Corrective & Preventive Actions (CAPA): Identify compliance gaps and collaborate with leadership to design and implement corrective measures and process improvements.
Risk Mitigation: Communicate significant regulatory risks or compliance deviations to local and global management in a timely and transparent manner.
Regulatory Alignment: Ensure that all GPC activities remain in full alignment with medical device regulations, pharmacovigilance standards, and data privacy laws.

Key Skills And Experience

Language: A fluent command of English is required; additional languages are a distinct advantage.
Experience: Minimum 4 years of experience in Quality Management, Regulatory Compliance, or Auditing, preferably within a medical device, pharmaceutical, or highly regulated environment.
Technical Knowledge: Strong understanding of Post Market Surveillance, Pharmacovigilance reporting, and relevant ISO standards.
Attention to Detail: Exceptional analytical skills with the ability to spot minute deviations in documentation or agent workflows.
Communication: Ability to communicate complex regulatory requirements to non-compliance stakeholders clearly and persuasively.
Organizing skills: Proven ability to manage audit schedules, meet strict deadlines, and coordinate multi-departmental preparation efforts.
Systems Literacy: Proficient in IT navigation and Quality Management Systems (QMS); ability to quickly learn new compliance tracking technologies.
Mindset: Highly ethical, detail-oriented, and resilient. You must be comfortable working with autonomy while maintaining a collaborative approach with global safety teams.

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.

For further information, and to apply, please visit our website via the Apply button below.

Candidates must be resident in Malaysia, or have the right to work in Malaysia.