Position Mission
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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
- Conduct regular, systematic compliance audits across all supported channels to ensure adherence to safety reporting and regulatory guidelines.
- Author, update, and maintain Standard Operating Procedures (SOPs) and relevant compliance documentation to reflect current global and local requirements.
- 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.
- 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.
- Actively participate in GPC-relevant audits, providing evidence, responding to inquiries, and managing the documentation trail.
- Identify compliance gaps and collaborate with leadership to design and implement corrective measures and process improvements.
- Communicate significant regulatory risks or compliance deviations to local and global management in a timely and transparent manner.
- 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. xpzdshu
Roche is an Equal Opportunity Employer.
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