Job Description
Are you ready to accelerate your career at the forefront of medical innovation? Nexus BioPharm Solutions is seeking a detail-oriented Senior Quality Assurance Specialist to join our elite team in Cambridge. We are dedicated to delivering life-saving therapies to global markets through rigorous compliance and process excellence.
In this role, you will be the guardian of our quality systems, ensuring every batch meets the highest standards of safety and efficacy. If you are passionate about GxP standards and want to make a measurable impact on patient lives, we invite you to apply.
Responsibilities
- Manage and oversee site Quality Management Systems (QMS) ensuring full adherence to FDA and EMA regulations.
- Conduct thorough internal and external audits to identify process gaps and drive continuous improvement.
- Lead investigation efforts for non-conformances, deviations, and CAPAs, providing actionable root cause analysis.
- Review and approve batch production records, analytical data, and validation protocols for release.
- Collaborate with cross-functional R&D and Manufacturing teams to facilitate seamless technology transfers.
- Prepare and update Standard Operating Procedures (SOPs) to ensure alignment with current industry best practices.
- Represent the Quality department during regulatory inspections and client-led compliance assessments.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- 5+ years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Deep understanding of cGMP, GxP, and 21 CFR Part 11 requirements.
- Proven ability to manage complex investigations and resolve technical compliance issues.
- Excellent communication skills with the ability to influence stakeholders at all organizational levels.
- Professional certification (e.g., ASQ-CPQ or similar) is highly preferred.
- Experience with electronic Quality Management Systems (eQMS) such as Veeva or TrackWise.