Desired Consultant Experience
Experienced QA professional or SME within the biotech/biologics sector; monoclonal antibody (mAb) experience strongly preferred
Proven ability to operate effectively at both strategic and operational levels
Deep understanding of QA oversight in outsourced or virtual company models, including CDMO, CTL, and CRO management
Strong working knowledge of applicable GMP and GCP regulations and guidelines (FDA, EMA, ICH)
Exceptional attention to detail and ability to manage multiple priorities in a fast-paced environment
Key Responsibilities
GMP QA Responsibilities
Collaborate with the CMC team and engage routinely with CDMOs and CTLs to support daily GMP operations (e.g., weekly meetings, deviation and change control review)
Review and approve master batch records, executed batch records, and Quality Technical Agreements (QTAs)
Provide QA support for process characterization, analytical method validation, process performance qualification (PPQ), and new product introductions (NPI)
Manage and drive completion of open change controls and deviations backlog
Ensure consistent QA oversight and documentation integrity across external manufacturing and testing partners
GCP QA Responsibilities
Partner with Clinical Operations, Clinical Development, and Pharmacovigilance teams to support daily GCP operations
Provide QA oversight for clinical trials (Phase 1b through Phase 2/3) conducted in the US and globally
Review clinical trial documentation (e.g., TORO, ICF, protocol revisions) and regulatory deliverables (e.g., CSR, DSUR)
Coordinate and oversee clinical vendor audits, including agenda preparation, report review, and CAPA follow-up
Support Trial Master File (TMF) management and auditing to ensure inspection readiness
Track and close findings from QA gap assessments, ensuring timely resolution
Qualifications
Bachelor’s degree in Life Sciences or related field; advanced degree preferred
10+ years of Quality Assurance experience in biotech, biologics, or pharmaceutical environments
Direct experience with CDMO and CRO oversight in a virtual or outsourced operating model
Strong interpersonal and communication skills to effectively engage cross-functional and external stakeholders
Ability to work independently while providing proactive, solutions-oriented QA support