Senior Quality Consultant - Cell & Gene Therapy

Job Description

Job Description

This is a 1099 consultant opportunity with no benefits.

Position Overview
We are seeking a Senior Quality Consultant with deep expertise in cell and gene therapy (CGT), Biologics License Application (BLA) readiness, and quality documentation. This is a consulting role focused on preparing a gene therapy company for commercial operations and regulatory submission.

The consultant will lead three critical workstreams:

1. Support documentation and change control for test method and site transfers
2. Evaluate stability data and refine product specifications based on PPQ outcomes
3. Author and align Quality Control (QC) Commercial SOPs to support post-approval GMP readiness

This role requires hands-on experience working with regulated biologic products and the unique requirements of cell and gene therapy manufacturing and release testing.

Key Responsibilities

• Review documentation and change controls related to test method and site transfers between contract labs and manufacturing sites
• Assess completeness and compliance of transfer records for inclusion in BLA submission
• Evaluate stability and PPQ data to support specification strategy and regulatory alignment
• Author and revise QC SOPs aligned with commercial readiness, cGMP requirements, and operational practices
• Collaborate with cross-functional stakeholders including Quality, Regulatory, Analytical, and CMO/CRO partners
• Provide subject matter expertise in CGT product validation, quality systems, and documentation practices
• Ensure deliverables are audit-ready and aligned with regulatory timelines

Required Experience

• 10+ years of experience in Quality Assurance, Quality Systems, or Validation within the life sciences industry
• Direct experience with BLA filings or comparable regulatory submissions (e.g., IND to BLA transitions)
• 5+ years of hands-on experience in Cell & Gene Therapy, including knowledge of viral vector production, sterility requirements, and associated release testing
• Expertise in stability program design, PPQ data analysis, and setting or revising specifications
• Proven track record in authoring GMP-compliant SOPs and quality documentation
• Strong understanding of test method transfer, change control, and data integrity principles
• Familiarity with cGMP for biologics, ICH guidelines, and FDA expectations for advanced therapies
• Proficient in working with CMOs, CROs, and QC labs in regulated environments

In addition to the qualifications outlined above, candidates must have:

1. QC Laboratory Leadership, Demonstrated experience managing or overseeing GMP QC laboratory operations (microbiology, chemistry, and/or bioassay), including staff oversight, scheduling and execution of testing, ensuring GMP compliance, and preparing QC labs for regulatory inspections.
2. QC BLA Requirements, Experience contributing to or leading preparation of the QC sections of a Biologics License Application (BLA), including analytical method validation/transfer, stability program data, product specifications, reference standard qualification, and responding to regulatory agency questions specific to QC.

Preferred Experience

• Experience preparing for or supporting FDA pre-approval inspections (PAI)
• Working knowledge of QMS platforms (e.g., MasterControl, Veeva Vault, TrackWise)
• Previous work on commercial readiness programs for emerging biotech or CGT companies
• Excellent technical writing and collaborative communication skills

This is a remote role with occasional travel.

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to [email protected].

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