Job Description
Are you ready to shape the future of medicine? Nexus BioPharm Solutions is at the forefront of clinical breakthrough, and we are seeking a meticulous Senior Quality Assurance Specialist to join our elite team in Cambridge. In this pivotal role, you will be the guardian of our compliance standards, ensuring that every therapeutic candidate meets rigorous global regulatory requirements before it reaches the patient.
We offer a dynamic, high-growth environment where innovation meets precision. If you are passionate about patient safety and operational excellence, we want to hear from you.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) to ensure full compliance with FDA and EMA regulations.
- Conduct comprehensive internal and external audits of clinical manufacturing processes.
- Manage batch record reviews, ensuring zero-defect documentation for pharmaceutical release.
- Lead CAPA investigations and implement robust root-cause analysis for quality deviations.
- Collaborate cross-functionally with R&D and Regulatory Affairs to streamline validation protocols.
- Provide expert guidance on cGMP training programs for laboratory and production personnel.
- Participate in regulatory agency inspections and represent QA during external audits.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related Life Sciences discipline.
- 5+ years of dedicated experience in pharmaceutical Quality Assurance within a cGMP environment.
- Deep understanding of 21 CFR Part 210/211 and ICH quality guidelines.
- Proven track record in managing CAPA and change control systems.
- Excellent analytical, critical thinking, and technical writing skills.
- Professional certification (e.g., ASQ CQA or CMQ/OE) is highly preferred.
- Strong interpersonal skills with the ability to lead compliance initiatives across multiple departments.