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Associate Director, QA Validation

Sana Biotechnology

Sana Biotechnology

Quality Assurance
Bothell, WA, USA
Posted on Tuesday, November 14, 2023

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 want to challenge status quo, and who lead with the desire to work on novel ideas. As the Associate Director, QA Validation, you will report to Director, Head of QA Validation, Technical Operation to provide quality oversight over equipment and computer system qualification and validation activities, EMPQ, Aseptic Process Simulation, Assay Qualification and Process Validation.

What you’ll do

  • Provide quality oversight for the qualification and validation activities supporting facility startup.
  • Oversee validation processes and deliverables. This includes the plans, protocols, requirements and reports
  • Ensure validation strategies and deliverables align with and adhere to relevant regulations and Sana procedures
  • Provide oversight for new equipment, process and method introduction.
  • Provide Quality oversight for ongoing changes to validated equipment and systems.
  • Support inspections by FDA, other regulatory agencies, and partners
  • Support the site to achieve site goals and maintain compliance to corporate quality standards and the regulatory agencies.
  • Participate in the strategic plans and goals for the site validation organization by making final quality decisions on plans and deliverables.

What we’re looking for

  • Familiar with the US, EMA, and ICH regulations and guidance documents
  • Demonstrate ability to engage team members across diverse teams
  • Promote curiosity, scientific rigor, and excellent problem-solving skills
  • Experience overseeing risk-based validation processes
  • Collaboration skills
  • Experience with Validation, Project Management and Analytics software
  • BA or MS in life science degree
  • 8+ years' experience or equivalent education and work experience
  • Strong knowledge of validation principles and application in the pharmaceutical industry including equipment, computer systems, utilities, processes and analytical methods

What will separate you from the crowd

  • Cell and Gene Therapy product experience
  • Successful facility startup and regulatory inspection experience

What you should know

  • This role may require you to enter the manufacturing floor and work with and around a variety of equipment and industrial utilities. You must be able to lift up to 25lbs and wear the required gowning and personal protective equipment to enter the cell therapy processing space
  • The role will be located in Seattle, WA until the Bothell manufacturing site is ready for occupancy
  • The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/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

  • 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.