Job Description
Are you ready to influence the future of drug development? Nexus BioPharm Solutions is seeking a detail-oriented Senior Quality Assurance Specialist to join our elite team in the heart of Cambridge's biotech hub. In this role, you will be the guardian of our compliance standards, ensuring that our life-saving therapies meet the highest regulatory expectations before they reach patients worldwide.
We offer a dynamic, collaborative environment where your expertise in GMP and regulatory affairs will be directly leveraged to streamline production and foster innovation. Join us and make a tangible impact on global health outcomes.
Responsibilities
- Oversee and manage QMS processes to ensure 100% compliance with FDA and EMA regulations.
- Conduct rigorous internal and vendor audits to mitigate operational risks.
- Review and approve batch production records, analytical data, and validation protocols.
- Lead root cause analysis (RCA) and corrective/preventative action (CAPA) investigations.
- Collaborate cross-functionally with R&D and Manufacturing to implement quality-by-design (QbD) principles.
- Manage documentation control systems and update SOPs to align with evolving industry standards.
- Support regulatory inspections and provide expert guidance during external audits.
Qualifications
- Bachelor’s degree in Chemistry, Pharmacy, Biology, or a related life science discipline.
- Minimum of 5-7 years of direct experience in pharmaceutical Quality Assurance.
- Deep working knowledge of 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex CAPA and Deviation workflows.
- Excellent communication skills with the ability to influence stakeholders at all levels.
- Prior experience with electronic Quality Management Systems (eQMS) such as Veeva or TrackWise.
- ASQ Certification (CQE or CQA) is highly preferred.