Job Description
Are you ready to drive excellence in life-saving therapeutics? Nexus BioPharm Solutions is seeking a detail-oriented Senior Quality Assurance Specialist to join our high-performing team in Cambridge. In this role, you will be instrumental in ensuring that our cutting-edge manufacturing processes meet the highest global regulatory standards, directly impacting patient outcomes worldwide.
We foster a culture of innovation, scientific rigor, and professional growth. Join us as we push the boundaries of pharmaceutical engineering and quality compliance.
Responsibilities
- Oversee and monitor GMP compliance throughout the entire drug development and manufacturing lifecycle.
- Lead internal and external audits to ensure adherence to FDA, EMA, and ICH regulatory guidelines.
- Manage CAPA processes, including the investigation of non-conformances and implementation of corrective measures.
- Review and approve batch records, validation protocols, and technical reports for accuracy and compliance.
- Collaborate with cross-functional teams including R&D, Clinical Operations, and Supply Chain to resolve quality-related issues.
- Develop and update Standard Operating Procedures (SOPs) to align with evolving industry benchmarks.
- Provide expert guidance on quality management systems (QMS) to ensure operational excellence.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline; Master’s preferred.
- Minimum of 5-7 years of direct experience in pharmaceutical Quality Assurance within a cGMP environment.
- Deep understanding of 21 CFR Part 210/211 and ICH Q7/Q10 guidelines.
- Proven ability to perform comprehensive Root Cause Analysis (RCA) and risk assessments.
- Strong analytical skills with a meticulous approach to documentation and technical writing.
- Excellent communication skills with the ability to lead audit presentations and interface with regulatory bodies.
- Experience with electronic Quality Management Systems (eQMS) such as Veeva or TrackWise.