Sr. Director, Clinical and Pre Clinical Quality Assurance

Role Summary

The Senior Director of Quality (GLP/GCP) will be responsible for the strategic approach to Quality that is phase appropriate. You will design, prioritize, implement, monitor, and communicate Sana's GLP/GCP quality strategy and quality programs, translate quality strategy into operational policies, procedures, and training to meet global regulatory standards. The role reports to the Chief Medical Officer and is based in Cambridge, MA with the office in use 3 days per week; some travel may be required.

Responsibilities

• In this highly visible role, you will oversee Quality-related activities that support non-clinical and clinical work.
• Provide senior-level leadership regarding GLP/GCP quality strategy and operations for leadership and cross-functional project teams.
• Oversee GLP quality and compliance of GLP bioanalysis.
• Review clinical study protocols and reports, and regulatory submissions.
• Manage and sustain a Quality Management System (QMS) that conforms to corporate standards and regulatory requirements and effectively implements this system across Sana.
• Provide leadership in the execution and management of the following:
• GLP and GCP audits (internal sites, clinical sites, CROs, contract test labs and contract service providers)
• Vendor qualifications and vendor management, including:
• Approval of Quality agreements.
• Collaboration and resolution of complex issues on supplier, partner, vendor performance.
• Quality investigations (QE, Deviation, CAPA),
• Review and approval of documents and
• Administration of training programs.
• Support program teams by providing direction on interpretation of global quality regulations and guidance documents.
• Identify, assess and mitigate potential challenges that could impact overall quality.
• Ensure Sana practices are compliant with regulatory requirements (FDA, ICH (R3), EMA) and industry standards.
• Establish and maintain procedures in collaboration with Development, Clinical Operations, Regulatory Affairs, and Technical Operations to ensure the nonclinical/clinical study activities are conducted according to GxP compliance regulations, guidelines, and practices.
• Identify and administers training needs related to GLP/GCP training for SOPs, policies, and clinical study specific training for GLP/GCP employees and ensure comprehensive training is provided to support compliance.
• Design, implement and maintain Quality systems that promote continual improvement of GLP/GCP
• Generate and analyze key performance metrics on a quarterly basis to track performance against quality objectives and standards, and report during quality management review meetings with leadership.
• Provide GLP/GCP quality guidance and partner with key stakeholders to resolve quality compliance issues and support with quality event management, protocol deviations, risk management, issue escalation and CAPA development. Ensure suitability of corrective and preventive actions, verifying CAPAs to completion and keeping management informed of CAPA metrics.

Qualifications

• Bachelor's degree required, advanced degree in relevant scientific field is a plus
• 8+ years of relevant experience within biotechnology or pharmaceutical industry; including in development of complex biologics (such as gene therapy, vaccines, monoclonal/conjugated antibodies, enzyme replacement therapies), and small molecules

Additional Requirements

• Some travel may be required