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

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

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