Director, External Quality Assurance

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas.  As a Director of External Quality Assurance, you will report to Head of Technical Quality to provide Quality oversight on manufacturing operations at Contract and Development Manufacturing Organizations (CDMOs).  The scope of work will include Sana’s programs from pre-clinical, clinical and subsequently commercial operations serving the US and ex-US regions.  The role will include performing Quality person in the plant (PIP) activities at CDMOs for critical operations.  This role will also require supporting external audits of Sana’s suppliers and contract services.  Approximately 30% travel may be required.

What you’ll do

• Provide leadership and quality oversight for operations at Sana CDMOs, which may require onsite support at the CDMO.
• Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs.
• Perform batch review and ensure timely and accurate batch disposition of materials and/or Sana products.
• Partner with technical departments to help ensure success of technical transfer activities from Sana to the CDMO partners.
• Partner with CDMO to identify and address gaps or areas for improvement in systems, procedures, and quality initiatives.
• Collaborate with other functions in CDMO Manufacturing, QC, and Process Development teams to evaluate, investigate and resolve issues.
• Responsible for batch release of Sana products manufactured at CDMOs.
• Understand the Quality Management System and influence phase-appropriate SOPs, change control, investigations, CAPA, compliance, document management, training management and validation.
• Establish and maintain Quality Technical Agreements and ensure alignment with other legal contracts as needed with CDMOs and CTLs.
• Maintain a Quality Risk Management system to identify and mitigate compliance risks.
• Ensure that CDMO facilities, utilities, and equipment are maintained in a validated or qualified state.
• Support qualification activities for suppliers, contract testing laboratories, contract manufacturing organizations and contract services.
• Perform supplier audits in accordance with Sana requirements.
• Support the complaint program; review and approve the complaint reports to ensure all quality complaints are thoroughly investigated and ensure the CAPA plans for the resolution of the complaints are developed and executed.
• Serve as the Sana business process owner for Quality batch disposition activities.
• Support inspection and/or audit readiness activities for inspections by Health Authorities, and partners.

What we’re looking for

• Self motivated leader who can influence others and exercise sound judgement when managing issues during critical operations.
• Experience in working with CDMOs in various product lifecycle stages.
• Operational experience in manufacturing aseptic environments, in quality or manufacturing.
• Experience in leading and managing complex investigations.
• Experience in batch disposition activities.
• Familiar with the US, EMA, and ICH regulations and guidance documents
• Effective communicator where you can articulate concerns and/or issues in a clear and concise manner.
• Demonstrated ability to engage team members across diverse teams.
• Ability to effectively prioritize and deliver high-quality results on tight timelines. 
• Demonstrated ability to independently problem solve including the ability to devise and implement practical solutions to resolve QA issues while being mindful of impact to timelines, resources and conflicting priorities.
• Experience in inspection readiness activities, presenting during inspections and/or hosting Health Authority inspections.
• Bachelors or Masters plus 10-12 years of work experience.
  

What will separate you from the crowd

• Cell and Gene Therapy product experience preferred
• Experience in expedited release processes

What you should know

• Approximately 30% travel may be required.
• The role will be based at the Sana Cambridge, MA location and will require onsite presence.
• The base pay range for this position at commencement of employment is expected to be between $200,000 - $250,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience