STARLIMS
One partner, one powerful solution.
Deputy Director, Quality and Regulatory Affairs
Location
United States
Posted
173 days ago
Salary
Not specified
Seniority
Lead
English
Job Description
• Administrative Support – scheduling meetings, preparing reports, and maintaining audit and CAPA schedules.
• Audit Support – prepare for internal and external quality audits by organizing documentation and ensuring compliance with relevant standards (ISO 9001 and ISO 27001) and HIPAA and GDPR regulations.
• Process Support – Assist in implementing and monitoring quality processes and systems to ensure they meet organizational standards and objectives.
• Training and Compliance - Manage internal employee training in the STARlearn (LITMOS) system, provide data on training completion rates, create training modules as needed, and ensure training is completed promptly.
• Data Collection and Analysis – Gather and organize quality-related data to support internal audits, management reviews, and continual improvement efforts; perform statistical analysis to identify trends.
• Continual Improvement – participate in projects aimed at improving the efficiency and effectiveness of the quality and information security management systems.
• Occasional travel as required.
Job Requirements
- Previous experience working with ISO 9001:2015 and ISO 27001:2022 standards, either as an internal or external auditor or Quality Assistant.
- Certification with ASQ or Exemplar Global is a plus.
- Self–starter – must be able to work with minimal supervision, pro-active, open to new concepts, and engage with others without prompting.
- Attention to Detail – must be meticulous in work approach to ensure accurate record-keeping and quality control.
- Organizational Skills – Must be able to manage multiple tasks, documents, and projects without reminders.
- Computer Proficiency – MS Office Suite, SharePoint, Salesforce, LITMOS LIMS, Zendesk.
- Statistical analysis background to analyze data and identify trends that support the QMS system.
- Problem solving – must be able to identify minor issues and contribute to finding solutions.
- Occasional travel.
Benefits
- Competitive health and Wellness (medical, dental, and vision)
- Retirement plan with matching company contribution
- Life Insurance and Disability/Income Protection
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