Job Description
Are you ready to shape the future of medicine? At Nexus BioPharm, we are accelerating the development of life-saving therapeutics. We are seeking a meticulous and forward-thinking Quality Assurance Specialist to join our world-class compliance team in the heart of Cambridge's biotech hub. You will play a pivotal role in ensuring our drug development processes exceed global regulatory standards.
This is a unique opportunity to work with cutting-edge drug delivery systems in a culture that values innovation, integrity, and scientific rigor.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) to ensure full compliance with FDA and EMA regulations.
- Conduct thorough internal and external audits of clinical trial processes and manufacturing operations.
- Review and approve batch records, validation protocols, and analytical reports for accuracy and compliance.
- Lead root cause analysis investigations for deviations and implement robust CAPA (Corrective and Preventive Actions) plans.
- Serve as a primary liaison during regulatory inspections and third-party audits.
- Collaborate with cross-functional teams to integrate Quality by Design (QbD) principles throughout the product lifecycle.
- Mentor junior quality personnel on best practices in Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5-7 years of experience in a regulated pharmaceutical or biotech quality role.
- Comprehensive knowledge of 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex regulatory filings and audit cycles.
- Exceptional analytical and technical writing skills for documentation management.
- Experience with electronic Quality Management Systems (eQMS) such as Veeva or TrackWise.
- Strong interpersonal skills with the ability to influence stakeholders at all levels of the organization.