Gpc Compliance Assurance Specialist

Roche & Company; Málaga; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

Roche is seeking a GPC Compliance Assurance Specialist to safeguard regulatory adherence across customer channels, manage audit schedules, and maintain critical documentation. You will liaise with Local Safety Officers and Global Post Market Quality teams to uphold safety reporting and quality standards.

With a strong background in Quality Management, regulatory compliance, and auditing, you will identify risks, implement corrective actions, and ensure alignment with medical device regulations

Formación

• English fluency required; additional languages a plus.
• Minimum 4 years in Quality Management, Regulatory Compliance or Auditing.
• Strong knowledge of Post Market Surveillance and Pharmacovigilance.
• Familiarity with ISO standards and regulatory frameworks.
• Detail-oriented with strong analytical skills.
• Ability to communicate regulatory requirements clearly.

Responsabilidades

• Conduct regular compliance audits across channels to ensure safety and regulatory guidelines.
• Author, update and maintain SOPs reflecting global and local requirements.
• Lead preparation and management of the GPC audit schedule.
• Coordinate with Local Safety Officers and Global Post Market Quality teams.
• Participate in GPC-relevant audits; provide evidence and manage documentation trail.
• Identify compliance gaps and implement corrective actions.
• Communicate regulatory risks to local and global management.
• Ensure activities align with medical device regulations and data privacy laws.

Conocimientos

English fluency

Regulatory compliance

Quality Management

Auditing

Attention to detail

Communication

Organizing skills

QMS familiarity

Herramientas

Quality Management System (QMS)

Descripción del empleo

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.

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.