Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- Quality & Compliance System Senior Specialist overseeing Quality Management Systems in a global biopharmaceutical company. Ensuring GMP compliance and continuous improvement in quality processes.
Responsibilities
- Developing and Implementing Quality Management Systems (QMS): this includes creating and updating procedures, processes, and documentation to meet quality standards.
- Monitoring and Analyzing Quality Data: tracking quality metrics, identifying trends, and pinpointing areas for improvement.
- Prepare and submit periodic reports on the performance of the quality management system to company management
- Working with Cross-Functional Teams: collaborate with other departments (e.g., production, engineering, procurement) to resolve quality issues and improve processes.
- Investigating Quality Issues: analyzing root causes of quality problems and developing corrective and preventative action plans.
- Quality System Governance: fostering a culture of quality and ongoing improvement throughout the site.
Requirements
- Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
- At least 5 years of experience in manufacturing sites within the pharmaceutical and biopharmaceutical sector, specifically in Quality Assurance, Production, and Process Technology departments
- Excellent knowledge of pharmaceutical guidelines (EU and FDA regulations)
- Specialized expertise in GMP compliance improvement processes
- Fluent English (both written and spoken)
Benefits
- comprehensive healthcare programs
- work-life balance initiatives
- robust relocation support
- flexible working arrangements
- remote work options
- tax assistance services for foreign colleagues
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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