Job Description
Are you ready to influence the future of drug development? 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 critical role in ensuring the integrity, safety, and compliance of our cutting-edge therapeutic pipelines.
In this role, you will champion a culture of quality, working cross-functionally with R&D, clinical operations, and manufacturing partners to navigate complex regulatory landscapes. We offer a sophisticated, collaborative environment designed for professionals who thrive on precision and excellence.
Responsibilities
- Oversee GxP compliance across all stages of pharmaceutical development and manufacturing.
- Perform comprehensive internal and vendor audits to ensure adherence to FDA and EMA standards.
- Lead CAPA investigations and root-cause analysis to mitigate risks and implement robust preventative measures.
- Review and approve batch records, validation protocols, and technical reports for accuracy and compliance.
- Provide strategic regulatory guidance to cross-functional teams during product development lifecycles.
- Manage the documentation control system and ensure all SOPs reflect current industry best practices.
- Facilitate regulatory inspections and act as a primary point of contact for external auditors.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field; Master’s preferred.
- Minimum of 5-7 years of direct experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- Expert-level knowledge of 21 CFR Part 210/211, ICH guidelines, and EU GMP regulations.
- Proven track record in managing CAPA systems and leading successful regulatory inspections.
- Strong technical writing proficiency and attention to detail for complex documentation.
- Exceptional communication skills with the ability to influence stakeholders across all levels of the organization.
- Professional certification (e.g., ASQ CQA or similar) is highly desirable.