Job Description
Are you ready to influence the future of drug development? Nexus BioPharm Solutions is seeking a detail-oriented Senior Pharmaceutical Quality Assurance Specialist to join our elite team in the heart of the Cambridge biotech hub. You will play a critical role in ensuring our cutting-edge therapeutic pipelines meet the highest global regulatory standards.
We offer a collaborative culture that values innovation, precision, and patient safety above all else. If you are passionate about compliance and operational excellence, we want to hear from you.
Responsibilities
- Oversee and monitor GxP compliance across all laboratory and manufacturing workflows.
- Conduct thorough internal audits and lead external regulatory inspections (FDA/EMA).
- Review and approve batch records, validation protocols, and analytical reports.
- Manage the CAPA (Corrective and Preventive Action) system to drive continuous process improvement.
- Provide expert guidance on quality risk management strategies for cross-functional teams.
- Ensure timely documentation and reporting of deviations, incidents, and investigation results.
- Lead training initiatives to maintain a culture of quality and regulatory awareness.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- 5+ years of direct Quality Assurance experience within the pharmaceutical or biotechnology sector.
- Comprehensive knowledge of FDA 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex audits and regulatory interactions independently.
- Strong analytical mindset with exceptional attention to technical detail.
- Excellent communication and stakeholder management skills in a matrixed environment.
- Professional certification (e.g., ASQ CQA) is highly preferred.