Key skills
Risk Management
About this role
Role Overview
- Collaborate with cross-functional teams to support sites in meeting regulatory standards and maintain inspection readiness.
- Assist sites to be inspection ready every day through coaching, training and educating.
- Conduct site and product assessments for regulatory compliance.
- Prepare for, conduct and manage Inspection Readiness support activities/Assessments of sites utilizing a risk-based approach.
- Provide support for all key Regulatory Inspections as needed.
- Review regulatory responses, conduct Global Assessments and participate in After Action Reviews.
- Share good practices and improvement opportunities across the organization.
Requirements
- Bachelors degree and 10+ years of experience in quality assurance or regulatory compliance within biotech, pharmaceuticals, or government agencies.
- Good knowledge of world-wide cGMPs and regulatory requirements; and experience in regulatory inspections, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, sterile.
- Proficiency & experience in identifying Regulatory Inspection Risks.
- Demonstrated expert knowledge and experience in one or more specific pharmaceutical dose forms or technologies, APIs, manufacturing processes and regulatory submissions.
- Broad based familiarity with Primary, Secondary manufacturing and Biopharmaceuticals, sterile manufacturing.
- Good knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and GMP compliance.
- Knowledge of risk management principles and application.
- Understanding and experience of corporate governance processes.
- Serious Incident management with demonstrated ability to resolve quality issues.
- Demonstrated improvement in processes associated with being inspection ready.
Benefits
- Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.