Executive Director, Head of Corporate Quality Control

The job overview for this role is that Sana Biotechnology is seeking an experienced Executive Director, Head of Corporate Quality Control (QC) to join their growing Quality team within Technical Operations. The role involves establishing and leading corporate QC policies, strategies, and testing operations at the Sana South San Francisco site. The Executive Director will also manage external testing sites, drive continuous improvement initiatives, and ensure compliance with regulatory requirements. The successful candidate will provide strategic direction, collaborate with key stakeholders, and oversee various QC activities to support clinical and commercial activities.

• Provide strategic direction and leadership to the Corporate QC function and implementation of CMC control strategies
• Ensure instrument and software qualification, exemplary QC data integrity, secure sample management, and effective QC document management
• Establish and manage collaborative relationships with key internal and external stakeholders
• Direct phase-appropriate assay transfer, assay qualification, and validation activities
• Ensure timely and accurate release of starting materials, raw materials, drug substances, and drug products
• Collaborate with other Tech Ops stakeholders in Process and Analytical development, Quality and Regulatory
• Support and follow on with critical technical Out Of Specifications (OOS) /Trend (OOT) Investigations
• Author and review relevant sections of CMC documentation in support of INDs, CTAs, BLA submissions, amendments, and briefing documents
• Participate in internal and external audits and ensure timely closure of audit findings
• Provide servant leadership to the QC team, including hiring, mentoring, career progression, and developing staff members
• Interface with Analytical Development, Quality Assurance, Process Development, CMC and Project Management, and Technical Operations Teams
• Monitor industry trends and emerging technologies to identify opportunities for improvement in quality control business processes
• Establish and maintain effective relationships with regulatory authorities, customers, and suppliers
• Manage and oversee the identification, procurement, installation, and maintenance of all critical laboratory equipment
• Contribute to Quality budget planning and approve proposed budgets for supporting teams and sub-functions
• Make sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders
• Communicate with facts, clarity, and authenticity up, down, and across organizations
• 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
• Expertise in phase-appropriate GMP testing and Lab Operations of cell therapies or biologics
• Expertise in qualification, validation, transfer, and life cycle management of analytical methods
• Experience in Health Authority Inspections, related observations, and implementation of CAPAs
• Proven record of highly developed communications (verbal and written) and ability to navigate highly collaborative workstreams with internal and external stakeholders
• Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills
• Proven track-record to collaborate effectively in a cross-functional matrix environment and lead with curiosity and influence across functional and organizational lines
• Ability to effectively work through change and ambiguity
• Ability to engage in crucial conversations – providing and receiving feedback.

• PhD in Chemistry, Biology, Bioengineering or related field with 10-15+ years of relevant industry experience. BA and/or MS with equivalent combination of education and work experience are considered
• 7-10+ years of managing GMP functions, vendor relations and technical professionals
• Expertise in phase appropriate GMP testing, and Lab Operations of cell therapies or biologics
• Expertise in qualification, validation, transfer and life cycle management of analytical methods
• Experience in Health Authority Inspections, related observations and implementation of CAPAs
• Proven record of highly developed communications (verbal and written), and ability to navigate highly collaborative workstreams with internal and external stakeholders
• Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines with excellent time management and organizational skills
• Proven track-record to collaborate effectively in a cross-functional matrix environment and lead with curiosity and influence across functional and organizational lines
• Ability to effectively work through change and ambiguity
• Ability to engage in crucial conversations – providing and receiving feedback

• 100% coverage of employee health coverage
• Generous time-off benefits (holidays, vacation, sick time, parental leave)
• Short- and long-term disability coverage
• Employer paid basic life insurance
• Additional voluntary life insurance protection
• Financial wellness programs and resources
• 401(k) Plan with an immediately vested employer match
• Tuition Reimbursement and Student Loan Repayment
• Employee Stock Purchase Plan
• Commuter subsidy
• Variety of wellness offerings to support each person individually
• Workplace free of discrimination and harassment
• Reasonable accommodations for individuals with disabilities