Job Description
Are you ready to elevate your career at the forefront of medical innovation? Nexus BioPharma is seeking a precision-driven Senior Quality Assurance Specialist to join our elite team in Cambridge. In this role, you will be the guardian of our product integrity, ensuring our groundbreaking therapies meet the highest global regulatory standards.
We offer a dynamic, collaborative culture where your expertise directly impacts patient outcomes. Join us in shaping the future of biopharmaceutical excellence.
Responsibilities
- Oversee GxP compliance across all manufacturing and laboratory workflows.
- Lead internal and external audits to ensure adherence to FDA and EMA guidelines.
- Manage CAPA processes and drive root cause analysis for quality deviations.
- Review and approve batch production records, analytical data, and validation protocols.
- Collaborate with R&D teams to implement quality-by-design (QbD) principles.
- Participate in the continuous improvement of the Quality Management System (QMS).
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Pharmacy, Biology, or related field.
- Minimum of 5-7 years of QA experience in the pharmaceutical or biotech industry.
- Deep understanding of cGMP, ICH guidelines, and 21 CFR Part 11 requirements.
- Proven ability to manage complex cross-functional compliance projects.
- Strong analytical mindset with attention to detail and data integrity.
- Exceptional verbal and written communication skills for regulatory reporting.