Job Description
Join BioGenix Therapeutics, a global leader in biopharmaceutical innovation, as we revolutionize patient care through cutting-edge therapies. We seek a meticulous Senior Quality Assurance Specialist to uphold our uncompromising standards in drug development and manufacturing. This pivotal role ensures compliance with FDA, EMA, and ICH guidelines while driving continuous improvement in quality systems. Collaborate with cross-functional teams in our state-of-the-art Boston facility to safeguard product integrity from lab to market.
Why BioGenix? Our commitment to excellence is matched only by our investment in talent. Enjoy comprehensive benefits, professional development grants, and the opportunity to impact lives through groundbreaking pharmaceutical research.
Responsibilities
- Oversee GMP compliance audits and validation protocols for biologics manufacturing processes
- Lead root cause investigations for quality deviations and CAPA implementation
- Develop and maintain robust quality documentation (SOPs, batch records, change controls)
- Collaborate with R&D and Production teams to integrate quality-by-design principles
- Represent QA during regulatory inspections and interactions with health authorities
- Mentor junior QA specialists and drive continuous improvement initiatives
- Monitor industry trends and emerging regulations to update quality systems
Qualifications
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field (MS/PhD preferred)
- Minimum 5 years of QA experience in GMP-regulated pharmaceutical/biotech environment
- Proven expertise in FDA/EMA regulatory requirements and ICH guidelines
- Strong knowledge of quality risk management (QRM) and validation methodologies
- Exceptional problem-solving skills with root cause analysis experience
- Excellent written communication for technical documentation and regulatory submissions
- Certified Quality Auditor (CQA) or similar certification highly desirable