Job Description
Are you ready to elevate your career at the forefront of life-saving innovation? Nexus BioPharm Solutions is seeking a detail-oriented and visionary Senior Quality Assurance Specialist to join our elite team in Cambridge, MA. In this role, you will play a pivotal part in maintaining the integrity of our drug manufacturing processes, ensuring compliance with global regulatory standards while fostering a culture of continuous improvement.
We offer a dynamic, collaborative environment where your expertise directly impacts patient outcomes. Join us in shaping the future of global healthcare.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) in alignment with FDA and EMA regulations.
- Conduct thorough internal and external audits to ensure rigorous adherence to cGMP standards.
- Lead root cause analysis investigations for deviations and implement effective CAPA (Corrective and Preventive Action) strategies.
- Review and approve batch production records, analytical data, and validation protocols for precision and compliance.
- Collaborate with cross-functional teams, including R&D and Manufacturing, to streamline production quality.
- Provide technical guidance on regulatory compliance during new product launches and facility expansions.
- Champion site-wide training initiatives to bolster quality culture and risk mitigation practices.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or a related Life Sciences discipline.
- Minimum of 5-7 years of direct experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- In-depth, hands-on knowledge of 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex regulatory inspections and interactions with health authorities.
- Strong analytical mindset with the ability to interpret technical data and identify systemic risks.
- Exceptional written and verbal communication skills for reporting and stakeholder engagement.
- Professional certification (e.g., ASQ-CMQ/OE) is highly desirable but not mandatory.