Job Description
Are you ready to influence the future of drug development? Nexus BioPharm is seeking a meticulous Senior Quality Assurance Specialist to join our elite team in the heart of Cambridge's biotech hub. You will play a pivotal role in ensuring our groundbreaking therapies meet the highest global regulatory standards, driving innovation from bench to bedside.
We offer a dynamic, collaborative culture where your expertise directly impacts patient lives. If you are passionate about compliance, process excellence, and rigorous quality systems, we want to hear from you.
Responsibilities
- Lead comprehensive internal and external quality audits to ensure adherence to cGMP and FDA regulations.
- Manage the CAPA process, investigating deviations and implementing effective root-cause corrective actions.
- Provide expert guidance to cross-functional teams on quality requirements during clinical trial phases.
- Review and approve batch records, validation protocols, and technical reports for accuracy and compliance.
- Oversee vendor qualification programs and maintain strong relationships with critical raw material suppliers.
- Develop and deliver specialized training programs to foster a culture of quality across the organization.
- Champion continuous improvement initiatives to streamline QMS efficiency and performance.
Qualifications
- Bachelor’s degree in Chemistry, Pharmacy, Biology, or a related life sciences field.
- 5+ years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- Expert-level knowledge of FDA 21 CFR Part 210/211 and EU GMP guidelines.
- Proven ability to navigate complex regulatory environments and manage high-stakes inspections.
- Strong analytical mindset with excellent attention to detail and documentation skills.
- Professional certification (e.g., ASQ CQA or similar) is highly preferred.
- Exceptional verbal and written communication skills with the ability to influence stakeholders at all levels.