Job Description
Are you ready to shape the future of medicine? BioGenix Innovations is seeking a meticulous and forward-thinking Senior Quality Assurance Specialist to join our high-impact team in the heart of the Cambridge biotech hub. In this pivotal role, you will ensure our cutting-edge therapeutic pipelines adhere to the highest global regulatory standards, directly impacting patient lives worldwide.
We offer a collaborative culture that values intellectual curiosity, rigorous scientific integrity, and professional growth. Join us as we push the boundaries of pharmaceutical excellence.
Responsibilities
- Oversee end-to-end QA activities for clinical-stage pharmaceutical manufacturing processes.
- Conduct thorough internal and vendor audits to maintain compliance with FDA, EMA, and GxP standards.
- Lead CAPA investigations and implement root cause analysis to mitigate production risks.
- Review and approve batch records, validation protocols, and technical reports for accuracy and compliance.
- Collaborate with cross-functional teams, including R&D and Regulatory Affairs, to streamline submission timelines.
- Manage document control systems and ensure all SOPs reflect current best practices and regulatory guidance.
- Mentor junior quality staff to build a culture of continuous improvement and operational excellence.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline (Master’s preferred).
- 5+ years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- In-depth knowledge of 21 CFR Part 11, cGMP, and ICH guidelines.
- Proven ability to manage complex investigations and technical documentation.
- Strong analytical mindset with excellent communication skills for stakeholder management.
- Experience with electronic Quality Management Systems (eQMS) such as Veeva or TrackWise.
- Professional certification (ASQ CQA or similar) is highly desirable.