Senior Quality Consultant â Cell & Gene Therapy
Senior Quality Consultant â Cell & Gene Therapy
Posted on :
09-08-2025
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1 Vacancy
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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:
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
Required Experience
Preferred Experience
This is a remote role with occasional travel.
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:
- Support documentation and change control for test method and site transfers
- Evaluate stability data and refine product specifications based on PPQ outcomes
- 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
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 @. If you receive a message that seems suspicious or is not from our official domain please report it immediately to
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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