Local Safety Officer – Quality & Regulatory
Roche
full-time
Posted on:
Location Type: Hybrid
Location: Riga • Latvia
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Salary
💰 €2,100 per month
About the role
- Authorize changes in post-market quality processes, maintain the QMS, and ensure local procedures meet Roche's global and local regulatory requirements.
- Initiate and monitor all safety-related activities, ensuring timely reporting of Safety Board Notifications (SBN) to local customers and authorities.
- Analyze and document current processes to identify areas for improvement and drive plans to enhance operational efficiency.
- Manage the quality standards for suppliers and distributors, including conducting audits and ensuring Quality Assurance Agreements are in place.
- Monitor changes in local regulations to ensure company policies and procedures remain compliant and provide regulatory guidance during product lifecycles.
- Serve as the local single point of contact for Global QMS requirements, collaborating with marketing, service, sales, and logistics teams to integrate quality and regulatory considerations into business operations.
Requirements
- Demonstrated background in quality and regulatory management, ideally within the pharmaceutical or biotechnological industry
- Expertise in maintaining Quality Management Systems (QMS), ensuring compliance and implementing internal controls; understanding of ISO standards
- Strong ability to identify quality risks and drive continuous improvement initiatives
- Quick to learn and proficient in specialized IT tools for case handling, promotional material review, regulatory review, improvement and resolution management, process mapping, QMS monitoring, certificate management, etc.
- Excellent communication and interpersonal skills, with the ability to influence cross-functional teams, lead negotiations, and resolve conflicting situations
- Strong ethical judgment while remaining agile in responding to evolving global regulations and standards
- Committed to accurate documentation and promoting a culture of compliance and excellence.
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management Systems (QMS)ISO standardsregulatory managementquality risk identificationcontinuous improvementprocess mappingaudit managementcompliance monitoringinternal controls
Soft Skills
communication skillsinterpersonal skillsinfluencing skillsnegotiation skillsconflict resolutionethical judgmentagilitycommitment to complianceattention to detail