Director – External Quality Assurance
Vendor Qualification
Posted on 1/24/2024
INACTIVE
Sana Biotechnology

201-500 employees

Engineers cells as medicines for untreatable diseases
Company Overview
Sana Biotechnology, Inc. stands out as a leading company in the cell and gene therapy industry, with a unique focus on using engineered cells as medicines to treat diseases with poor outcomes or that are currently untreatable. Their competitive edge lies in their advanced delivery technologies, their ability to differentiate pluripotent stem cells into immune-cloaked functional cells, and their commitment to scalable manufacturing solutions. The company's culture is deeply rooted in impacting patients' lives, as evidenced by their ongoing development of diverse drug candidates aimed at broadening treatment possibilities.
Biotechnology

Company Stage

N/A

Total Funding

$865M

Founded

2018

Headquarters

Seattle, Washington

Growth & Insights
Headcount

6 month growth

-13%

1 year growth

-18%

2 year growth

-10%
Locations
Remote in USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Management
Quality Assurance (QA)
CategoriesNew
QA & Testing
Quality Assurance
Requirements
  • PhD in scientific discipline with 5+ years experience in academic research and/or R&D environment or a Bachelors or Masters with 8+ 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
  • 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
Responsibilities
  • Provide leadership and oversight for GxP QA externally at vendors/suppliers and internally at Sana
  • Responsible for vendor qualifications and external/internal audits and regulatory inspections
  • Understand the Quality Management System and ensure establishment of SOPs, change control, investigations, CAPA, compliance, document management, training management, and validation
  • Responsible for material release function and ensure the manufacturing and testing of material are in accordance with FDA, ICH, EU, and other country-specific regulations including GxP practices
  • Monitor vendor/supplier performance. Partner with vendors/suppliers to identify and address gaps or areas for improvement in systems, procedures, and quality initiatives
  • Escalate and present issues at QRB as appropriate
  • Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues
  • Collaborate with Sana or Vendor Manufacturing, QC, and Process Development teams to evaluate and investigate 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 vendors and CTLs
  • Review and approve the vendors/suppliers, contract testing laboratories, and other services provided
  • Represent Quality at internal and external project team meetings and build relationships with Quality counterparts at Vendors, CTLs, and CDMOs
  • Maintain a Quality Risk Management system to identify and mitigate compliance risk
  • Ensure that Vendor facilities, utilities, and equipment are maintained in a validated or qualified state
  • Support approval of 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 Vendors 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