Director, CSV IT Lead

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 Director, IT CSV Lead, you will report to the Vice President, IT and will work with Quality and other departments to oversee end-to-end computer system validation in order to be in compliance with GXP guidelines. Important and cool stuff.

What you’ll do 

• Work with Quality to define a phase appropriate CSV program for Sana
• Create and/or revise CSV procedures, forms, and templates for continuous improvement
• Provide support for the CSV program, including writing, reviewing, and approving CSV deliverables such as Change Controls, Plans, Specifications (e.g., URS), Traceability Matrices, Test Scripts, and Reports
• Own CSV-related Deviations and CAPAs. Manage remediation efforts related to CSV and Data Integrity
• Perform and lead computer system validation projects related to authoring and executing specifications and validation documentation
• Partner with System/Process Owners to implement and maintain GxP computerized systems in a validated state and adhere to Data Integrity principles in accordance with external regulatory expectations and internal requirements
• Facilitate Periodic Reviews for systems. Ensure adherence to the Periodic Review schedule 
• Perform Audit Trail review requirements with IT and System/Process Owners 
• Provide training for the CSV program to new System/Process Owners 
• Lead or support GxP computer system audits and ensure computer system vendors are qualified prior to system implementation 
• Manage computerized systems regulatory compliance across the end-to-end product lifecycle for software development and validation lifecycle activities associated with GxP systems to ensure conformance to regulations, guidance documents, applicable industry standards 
• Provide support during audits and inspections

What we’re looking for

• Bachelors’ degree at an accredited institution
• 7+ years of CSV experience in a pharmaceutical biotechnology environment, preferably in a Quality Assurance (QA) role
• GxP computer systems experience
• Working knowledge of GxP regulations and CSV/CSA principles, including, 21 CFR Parts 312, 210, 211 and 11, Annex 11, GAMP 5, ICH E6(R1) and Data Integrity 
• Deep knowledge of Quality Risk Management per ICH Q9 and its application to CSV
• Deep knowledge of CSV expectations for the implementation and management of cloud-based/SaaS systems
• Deeply curious; maintains awareness of current and upcoming FDA Computer Software Assurance (CSA) principles
• Excellent oral and written skills, allowing for an open and effective dialogue throughout the company
• Proficiency in Microsoft Office, including process mapping/project management tools such as Visio, Smartsheet and Project

What will separate you from the crowd

• SOX compliance experience
• Bachelor’s degree in Computer Science, Engineering or related discipline preferred
• Veeva, LabVantage experience
• Familiarity with ERP and Clinical Data Management systems 

What you should know 

• Some travel will be required
• Working safely in person on a predictable and regular in-person basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC
• The base pay range for this position at commencement of employment is expected to be between $210,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
• 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.  Details of participation in these benefit plans will be provided if a candidate receives an offer of employment

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.

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.