Job Description
Are you ready to shape the future of medicine? Nexus BioPharm Solutions is at the forefront of clinical breakthrough, and we are looking for a visionary Senior QA Specialist to join our elite compliance team in Cambridge. In this role, you will be instrumental in ensuring our cutting-edge manufacturing processes meet the highest global standards for patient safety and efficacy.
We offer a dynamic, collaborative culture, state-of-the-art facilities, and a career trajectory that moves as fast as our science. If you have a passion for precision and a commitment to pharmaceutical integrity, 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 thorough internal audits and manage external vendor qualification programs.
- Manage Deviations, CAPAs, and Change Control processes with a focus on root cause analysis.
- Provide expert guidance to manufacturing teams on GMP best practices and facility compliance.
- Lead regulatory inspection readiness programs and serve as a key point of contact for external auditors.
- Review and approve batch records and analytical documentation to ensure data integrity.
- Develop and deliver specialized training programs to enhance organizational quality culture.
Qualifications
- Bachelor’s degree in Chemistry, Biology, Pharmacy, or related Life Sciences field; Master’s preferred.
- Minimum of 5-7 years of direct experience in pharmaceutical or biotech Quality Assurance.
- Deep working knowledge of 21 CFR Part 210/211 and ICH guidelines.
- Proven track record of managing successful regulatory agency inspections (FDA/EMA).
- Exceptional attention to detail and ability to analyze complex data sets for compliance gaps.
- Strong interpersonal skills with the ability to influence cross-functional teams.
- Relevant certification such as ASQ Certified Quality Auditor (CQA) is highly desirable.