Electra-Sr. QA Consultant; GMP​/GCP

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

• 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

• 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

• 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