Job Description
Are you ready to influence the future of drug development? At Nexus BioPharm, we are engineering the next generation of life-saving therapeutics. We are seeking a meticulous and forward-thinking Senior Quality Assurance Specialist to join our elite team in the heart of Cambridge's biotech hub.
This role is designed for a professional who thrives on precision, regulatory rigor, and cross-functional collaboration. You will serve as the guardian of our clinical production standards, ensuring that every batch meets the highest global compliance benchmarks.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) in accordance with cGMP standards.
- Lead internal and external audits to ensure comprehensive facility and supply chain compliance.
- Review and approve batch production records, analytical data, and SOPs for clinical-stage products.
- Manage CAPA processes and provide root-cause analysis for quality deviations.
- Collaborate with R&D and manufacturing teams to integrate quality-by-design (QbD) principles early in the development lifecycle.
- Represent the QA department in regulatory agency inspections and inquiries.
- Mentor junior quality staff to foster a culture of quality-first operational excellence.
Qualifications
- Bachelor’s degree in Chemistry, Pharmacy, Biology, or a related scientific discipline.
- Minimum of 5-7 years of direct experience in a pharmaceutical or biopharmaceutical QA environment.
- Deep understanding of FDA 21 CFR Parts 210/211 and EMA regulatory requirements.
- Proven track record in managing complex quality deviations and change control procedures.
- Excellent communication skills, with the ability to bridge technical data and executive decision-making.
- ASQ Certification or relevant Six Sigma green/black belt preferred.
- Proficiency in document management software and electronic QMS platforms (e.g., Veeva, TrackWise).