Associate Director for Contracts providing senior - level leadership in negotiating complex research agreements. Overseeing compliance and operational procedures in grants and contracts within Rice University.
About the role
- Quality Inspection Readiness Director ensuring regulatory compliance and continuous improvement at GSK. Collaborating with teams to maintain inspection readiness across global sites.
Responsibilities
- 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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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