Job Description
Are you ready to shape the future of medicine? Nexus BioPharm Solutions is seeking a detail-oriented and strategic Senior Quality Assurance Specialist to join our elite team in the heart of Cambridge. In this role, you will play a pivotal part in ensuring our drug development processes meet the highest global standards, directly impacting patient outcomes worldwide.
We offer a collaborative culture, cutting-edge laboratory facilities, and a commitment to professional growth.
Responsibilities
- Lead rigorous internal and external audits to ensure strict compliance with FDA and EMA regulations.
- Review and approve Batch Production Records (BPR) and analytical data for pharmaceutical releases.
- Drive continuous improvement initiatives by conducting root cause analysis and implementing CAPA (Corrective and Preventive Action) strategies.
- Collaborate with cross-functional R&D and manufacturing teams to integrate Quality by Design (QbD) principles.
- Manage document control systems and ensure all SOPs reflect current regulatory requirements.
- Support regulatory inspections and act as a key liaison for agency communications.
- Oversee supplier quality management, including the audit and qualification of external vendors.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or a related scientific field.
- Minimum of 5-7 years of direct Quality Assurance experience in a pharmaceutical or biotech environment.
- Expert-level knowledge of cGMP, GLP, and 21 CFR Part 11 compliance.
- Proven ability to manage complex investigations and technical documentation.
- Strong analytical, problem-solving, and cross-functional leadership skills.
- Exceptional written and verbal communication skills for technical and regulatory reporting.
- ASQ Certification or similar quality management professional certifications are highly desirable.