Quality Assurance SME (GCP/GMP) Biotech

Our client is working with a pre-commercial biotech company that is building its Quality Assurance (QA) organization from the ground up. As they scale, they need a subject matter expert (SME) in Quality Assurance to help drive key responsibilities and ensure compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP). We are seeking an experienced GCP or GMP Manager to help support the development of the Quality Assurance function. The SME will collaborate with key vendors, stakeholders, and internal teams to ensure quality processes align with industry regulations and company standards. Key Responsibilities: Oversee and manage QA activities related to GCP or GMP compliance Work closely with key vendors and stakeholders to ensure regulatory alignment Support quality audits, risk assessments, and compliance initiatives Assist in building and implementing QA policies and procedures Collaborate with cross-functional teams to drive continuous quality improvements Qualifications: 5+ years of experience in Quality Assurance within the biotech or pharmaceutical industry Expertise in GCP or GMP compliance Experience working with vendors, audits, and regulatory agencies Strong understanding of FDA, ICH, and other relevant regulations Ability to work onsite in Boston, MA (most of the week) Strong communication and stakeholder management skills Start Date: Early March Duration: 12 weeks Time Commitment: Full-time, 40 hours a week Location: Boston, MA (Onsite) Compensation: $100 - $125 per hour Project ID: 5136 **This is a 1099 role and does not offer health benefits