Executive Director, Head of External Quality

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 the Executive Director, Head of External Quality, you will report to the Vice President, Head of Quality, Technical Operations.  You will provide the strategic leadership and drive the execution of the External Quality organization. 

What you’ll do

• Provide strategic and technical leadership in selection and qualification of Partners, CDMOs, and Suppliers
• Provide strategic and technical leadership in developing policies and procedures regarding oversight of CDMOs and Suppliers
• Provide Quality leadership to the joint technical teams to meet key program timelines and goals
• Oversee day-to-day operational performance of Sana CDMOs network and external GMP suppliers
• Act as senior Quality liaison between Sana and the CDMO
• Partner with our technical departments to help ensure success of tech transfer activities from Sana to the CDMO partner(s)
• Partner with External Manufacturing Leads and key stakeholders to identify, notify, and/or escalates risks and issues that may affect project timelines or product quality related to the GMP activities
• Execute strategies that ensure high Quality performance and adherence to Quality Agreements with CDMO partners
• Review and facilitate approval of Quality Agreements, Changes, Deviations, and investigations with CDMOs and Suppliers
• Perform batch record reviews and Quality lot dispositions
• Effectively communicate project, performance, and Quality issues to senior management and within project teams
• Ensure CDMOs deliver to support Sana’s business needs including ensuring flexibility to accommodate changing program timelines and compliance with GMP practices as well as Sana's quality expectations
• As a member of the Quality leadership team, develop the organization strategy, champion the Sana Quality culture and make it a great place to work
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment
• Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

• Bachelor, Masters or PhD in pertinent science or engineering fields; 15 years plus of Quality oversight of suppliers and outsourced clinical and/or commercial manufacturing experience in the biotech/pharmaceutical industry
• Knowledge and understanding of global regulations and guidelines and working experience in the GMP environment
• Experience in early clinical stage, late stage, and commercial stage of products
• Demonstrated track record in Quality risk management and decision making
• Ability to communicate across all levels of an organization and effectively influence both internal and external customers.
• Proven ability to problem solves, build strong relationships, and have a high degree of self-motivation
• Quality acumen with an ability to anticipate compliance issues and proactively recommend mitigations/solutions
• Ability to quickly adapt to changing business conditions

What will separate you from the crowd

• Prior Quality experience with Cell and Gene products, supporting E2E supply chain CDMOs and Suppliers

What you should know

• Up to 30% travel (domestic and/or international)
• The base pay range for this position at commencement of employment is expected to be between $275,000 and $325,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

How we work together for patients

• Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
• Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
• Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution 

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many h