Head of Quality

Skills

Responsibilities

• Responsible for the development, implementation, and strict adherence to a GxP quality program.
• Develop phase-appropriate processes and procedures for Roivant as well as select Vants, as needed.
• Oversee the drug substance, drug product, packaging/labeling/serialization, third-party logistics vendors for production activities of early and late-phase therapeutic areas.
• Review and approve specifications affecting product quality and oversee the development of batch records, validation protocols.
• Review and resolve quality issues with stakeholders and others including vendors, internal customers, and production personnel.
• Prepare Quality Metrics for senior leadership supporting the quality function.
• Ensure the appropriate Quality Management Systems in place to ensure GxP compliance.
• Develop mutually agreeable Quality Agreements with Tier 1 vendors and Vants. Support inspection readiness activities and associated Health Authority Inspections.
• Develop/implement department-specific standards and SOPs in support of the Quality System to satisfy best practices and regulatory requirements.
• Work with management of GxP-regulated internal groups to identify process improvements for building compliance into the design and conduct of clinical activities.
• Collaborate to ensure management of GxP regulated internal groups are actively engaged in improving compliance and addressing compliance risks.
• Evaluate GxP compliance status in relationship to industry and Regulatory Agency expectations and assess the effectiveness of corrective actions in response to internal and third-party audits.

Benefits