Global Quality Assurance Specialist

About the role

We are seeking an experienced Global Quality Assurance Specialist to support the implementation, maintenance, and continuous improvement of the global Quality Management System (QMS) across clinical-stage cell and gene therapy programs. This role will report directly to the Senior Director, Global QA & CMC and will play a key role in global training oversight, document lifecycle management, cross-site compliance, and quality system execution. Additionally, this role will support the development and implementation of a fit-for-purpose QC laboratory quality system for our analytical testing laboratory in West Palm Beach, including procedures, training, data integrity, and inspection readiness. This is a highly hands-on role requiring strong GMP knowledge, excellent documentation skills, and the ability to operate effectively in a fast-paced, globally distributed organization.

Responsibilities

• Global Quality Management System (QMS)
  • Support the implementation, maintenance, and continuous improvement of our global QMS in compliance with applicable FDA, EMA, and ICH guidelines.
  • Manage and support core quality system processes, including:
    • Deviations, investigations, and root cause analysis
    • CAPA development and effectiveness verification
    • Change control
    • Document control and periodic review
    • Management review support and metrics tracking
  • Author, review, and approve quality documents including SOPs, work instructions, policies, forms, and quality plans.
  • Ensure alignment between global quality standards and site-specific implementation.
• Global Training Program
  • Manage and administer the global GMP training program, including:
    • New hire onboarding
    • Role-based training assignment
    • Training effectiveness and compliance tracking
  • Ensure training records are accurate, complete, and inspection-ready.
  • Support development and periodic maintenance of training matrices and curricula across functional groups (QA, QC, PD, Manufacturing, R&D).
• QC Laboratory Quality System (West Palm Beach – 4th Floor)
  • Support the design, implementation, and maintenance of a QC laboratory quality system for analytical testing activities.
  • Author and review QC-specific procedures, including (as applicable):
    • Sample management and chain of custody
    • Data integrity and documentation practices
    • Equipment qualification, calibration, and maintenance oversight
    • Laboratory investigations and OOS/OOT support
  • Partner with QC, Analytical Development, and Facilities to ensure quality system integration into daily lab operations.
  • Support readiness for internal audits, partner audits, and regulatory inspections related to laboratory activities.
• Audits, Vendors, and External Partners
  • Support internal audits and participate in external audits of vendors, CROs, and CDMOs, as assigned.
  • Support qualification and ongoing oversight of quality-critical vendors.
  • Track and follow up on audit commitments and CAPAs.
• Systems & Compliance Support
  • Support validation, maintenance, and continuous improvement of electronic quality systems (e.g., document management, training, alarms, inventory, e-signatures).
  • Ensure compliance with data integrity principles (ALCOA+) across quality and QC laboratory records.
  • Support cross-functional initiatives and quality risk assessments as needed.

Qualifications

• Required
  • Bachelor’s degree in life sciences or related field.
  • 7+ years of experience in Quality Assurance within biotech, pharmaceutical, or cell and gene therapy environments.
  • Strong working knowledge of GMP, including FDA and international expectations.
  • Hands-on experience with global quality systems (training, deviations, CAPA, change control, document control).
  • Experience supporting or interfacing with QC laboratories or analytical testing environments.
  • Excellent technical writing, document review, and communication skills.
  • Ability to work independently, manage multiple priorities, and collaborate across functions and geographies.
• Preferred
  • Experience in cell and gene therapy, viral vectors, or complex biologics.
  • Experience supporting early-stage to clinical-stage programs.
  • Familiarity with electronic QMS platforms and inspection readiness activities.
  • Experience supporting U.S. regulatory inspections or ex-U.S. inspections.

Job Identifier: #9860