Executive Director, Head of External Quality

2 weeks ago

Seattle, Washington, United States Sana Biotechnology Full time

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 human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.

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