Job Description
Are you ready to shape the future of medicine? Nexus BioPharm Solutions is at the forefront of biopharmaceutical innovation, and we are seeking a detail-oriented Senior Quality Assurance Specialist to join our elite team in Cambridge, MA. In this pivotal role, you will champion quality excellence, ensuring our breakthrough therapies meet the highest global regulatory standards.
We offer a collaborative culture that values intellectual curiosity, scientific rigor, and the relentless pursuit of patient safety.
Responsibilities
- Oversee comprehensive QA oversight for commercial drug manufacturing processes.
- Manage complex CAPA (Corrective and Preventive Action) investigations to identify and mitigate operational risks.
- Conduct rigorous internal and external audits to ensure ongoing compliance with cGMP regulations.
- Review and approve batch production records, ensuring 100% data integrity and consistency.
- Lead cross-functional teams in the implementation of Quality Risk Management (QRM) strategies.
- Facilitate regulatory inspections and represent the QA department in agency interactions.
- Mentor junior quality associates and foster a culture of quality-first thinking across the laboratory.
Qualifications
- Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific discipline.
- Minimum of 5-7 years of direct Quality Assurance experience in a regulated pharmaceutical environment.
- Deep understanding of FDA 21 CFR Part 210/211 and EMA guidelines.
- Proven track record in managing deviation investigations and change control processes.
- Exceptional analytical skills with a focus on meticulous documentation and reporting.
- Professional certification (e.g., ASQ Certified Quality Auditor) is highly preferred.
- Strong interpersonal skills with the ability to influence and lead technical stakeholders.