Job Description
Are you ready to shape the future of medicine? Nexus BioPharm is seeking a high-caliber Quality Assurance Specialist to join our elite team in the heart of the Cambridge biotech hub. You will play a pivotal role in ensuring our drug development processes meet the highest global regulatory standards, directly impacting patient lives worldwide.
We offer a dynamic, collaborative culture, state-of-the-art facilities, and a career path designed for leaders in the life sciences industry.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) in compliance with cGMP and FDA requirements.
- Conduct internal and external audits to identify process gaps and implement robust corrective and preventive actions (CAPA).
- Review and approve batch production records, analytical data, and validation protocols for clinical supply.
- Collaborate with cross-functional R&D and manufacturing teams to ensure quality is integrated into every stage of development.
- Lead regulatory inspection readiness programs and serve as a key point of contact for external auditors.
- Provide expert guidance on change control, deviations, and laboratory investigations.
- Drive continuous improvement initiatives to enhance site-wide quality culture and operational excellence.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related life science discipline.
- Minimum of 5-7 years of professional experience in Pharmaceutical Quality Assurance.
- Deep working knowledge of FDA 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex investigations and CAPA processes within a cGMP environment.
- Strong analytical mindset with excellent attention to detail and documentation standards.
- Exceptional communication skills, capable of influencing stakeholders at all organizational levels.
- Professional certification (e.g., ASQ CQA or CMQ/OE) is considered a significant asset.