Job Description
Are you ready to shape the future of medicine? Nexus BioPharm Solutions is at the forefront of innovative drug development in the heart of Cambridge's biotech corridor. We are seeking a meticulous and forward-thinking Senior Quality Assurance Specialist to ensure our life-changing therapies meet the highest standards of safety, efficacy, and regulatory compliance.
In this high-impact role, you will lead quality oversight for clinical manufacturing and ensure seamless integration of GxP standards across our research pipeline.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) to ensure continuous compliance with FDA and EMA regulations.
- Conduct thorough internal and external audits of clinical manufacturing sites and laboratory partners.
- Review and approve Batch Production Records (BPRs) and associated laboratory documentation to ensure product release integrity.
- Lead root-cause investigations for deviations and implement robust Corrective and Preventive Actions (CAPA).
- Collaborate with cross-functional teams to provide QA guidance during technology transfer and process validation activities.
- Mentor junior quality staff and foster a culture of quality excellence throughout the organization.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related life science field (Master’s preferred).
- Minimum of 5-7 years of professional experience in Pharmaceutical QA/QC within a cGMP environment.
- Deep understanding of 21 CFR Part 210/211 and ICH guidelines.
- Proven track record in managing CAPA and change control systems effectively.
- Strong analytical mindset with the ability to interpret complex technical data.
- Excellent communication and stakeholder management skills.
- ASQ Certification or similar quality management credentials are highly desirable.