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External Quality Assurance (PIP), Director

Sana Biotechnology

Sana Biotechnology

Quality Assurance
San Francisco, CA, USA · United States · Remote
Posted on Wednesday, January 24, 2024

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 an External Quality Assurance person, you will report to the Executive Director, External Quality to support Sana programs from early-stage to late-stage as a SME and Person-In-Plant at CDMO(s). Cool stuff.

What you’ll do

  • Provide leadership and oversight for GxP QA externally at CDMO and internally at Sana
  • Responsible for all quality-related matters related to manufacturing, testing and release at CDMO
  • Understand the Quality Management System and influence phase-appropriate SOPs, change control, investigations, CAPA, compliance, document management, training management and validation
  • Review and approve batch records, certificates of analysis/testing and compliance, in-process and release test methods, product specifications, stability protocols/reports, analytical method validations, technical study reports, trending reports, etc. Oversee the product release function and ensure the manufacturing and testing of products are in accordance with FDA, ICH, EU, and other country-specific regulations including GxP practices before the release of the products
  • Responsible for CDMO qualifications and external/internal audits and regulatory inspections
  • Partner with CDMO to identify and address gaps or areas for improvement in systems, procedures, and quality initiatives
  • Collaborate with Sana and CDMO Manufacturing, QC, and Process Development teams to evaluate and investigate issues
  • Escalate and present issues at QRB as appropriate
  • Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues
  • Support review and authoring of regulatory filing activities
  • Establish and maintain Quality Technical Agreements and ensure alignment with other legal contracts as needed with CDMOs and CTLs
  • Review and approve the suppliers of raw materials, contract testing laboratories, contract manufacturing organizations, and other services provided
  • Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at CDMOs and CTLs
  • Maintain a Quality Risk Management system to identify and mitigate compliance risk
  • Ensure that CDMO facilities, utilities, and equipment are maintained in a validated or qualified state
  • Approve the qualifications and validation master plans, validation/qualification reports and ensure the execution of all qualifications/validations in a timely manner
  • Support the internal and external audit program; author, review and/or approve audit plans, reports, and CAPA plans
  • Resolve and assist in solving compliance and customer issues
  • Support the complaint program; review and approve the complaint reports to ensure all quality complaints are thoroughly investigated and ensure the CAPA plans for the resolution of the complaints are developed and executed
  • Demonstrate ability to engage and effectively influence CDMO and internal team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
  • Ensure effective communication with Sana quality team especially manager and Head of Quality

What we’re looking for

  • PhD in scientific discipline with 8-9 years experience in academic research and/or R&D environment or a Bachelors or Masters plus 10-12 years or equivalent combination of education and work experience
  • Experience in hosting FDA, EMA, and other regulatory agencies’ inspections
  • Excellent written and oral communication skills
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Ability to communicate issues with CDMO
  • Goal oriented with the ability to troubleshoot and resolve problems
  • Strong interpersonal skills, with experience in leading high-performance team and cross functional projects
  • Team building and managing skills including recruiting, coaching, counseling, and disciplining

What will separate you from the crowd

  • Experience at a startup or pre-clinical biotechnology company; cell or gene therapy experience is a plus. Experience in taking program at CDMO into late stage
  • Excellent ability to work collaboratively in a complex, matrix, fast-paced environment
  • Excellent written and verbal communication
  • Ability to effectively prioritize and deliver high-quality results on tight timelines
  • Demonstrated ability to independently problem solve including the ability to devise and implement practical solutions to resolve QA issues while being mindful of impact to timelines, resources, and conflicting priorities

What you should know

  • Approximately 30% travel may be required
  • Position is per-in-plant (PIP) at CDMO(s)
  • The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

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.