GPC Compliance Assurance Specialist

As a GPC Compliance Assurance Specialist, you will safeguard the Global Patient Care (GPC) Organization by ensuring adherence to regulatory requirements, internal SOPs, and safety protocols. You will transition service quality into a rigorous model of Compliance Monitoring across all customer channels and serve as the primary point of contact for maintaining an 'Inspection Ready' status.

Key Accountabilities

• Conduct systematic compliance audits across all channels to ensure adherence to safety reporting and regulatory guidelines.
• Author and maintain SOPs and compliance documentation to reflect global and local requirements.
• Lead the preparation and management of the GPC audit schedule and coordinate pre-work for inspections.
• Act as the liaison for Local Safety Officers and Global Post Market Quality teams.
• Participate in audits by providing evidence and managing documentation trails.
• Identify compliance gaps and implement corrective and preventive actions (CAPA).
• Communicate regulatory risks to management and ensure alignment with medical device regulations, pharmacovigilance standards, and data privacy laws.

Key Skills and Experience

• Fluent English; additional languages are an advantage.
• Minimum 4 years of experience in Quality Management, Regulatory Compliance, or Auditing within a highly regulated environment.
• Strong understanding of Post Market Surveillance, Pharmacovigilance reporting, and ISO standards.
• Exceptional analytical skills and attention to detail.
• Ability to communicate complex regulatory requirements to non-compliance stakeholders.
• Proven ability to manage audit schedules and coordinate multi-departmental efforts.
• Proficiency in Quality Management Systems (QMS) and IT navigation.
• Highly ethical, detail-oriented, and resilient mindset.