Overview
Quality Assurance SME (GCP/GMP) – Biotech Jobs in Boston, MA at Umbrex
Title: Quality Assurance SME (GCP/GMP) – Biotech
Company: Umbrex
Location: Boston, MA
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
