Job Description
Are you ready to shape the future of medicine? At Nexus BioPharm, we are accelerating the development of life-saving therapies in the heart of the Kendall Square biotech hub. We are seeking a precision-oriented Senior QA Specialist to ensure our manufacturing processes exceed global regulatory standards and patient safety expectations.
You will join a high-impact team where innovation meets compliance, working directly with cross-functional departments to drive operational excellence in a cGMP environment.
Responsibilities
- Lead internal and external quality audits to ensure strict adherence to FDA and EMA regulatory requirements.
- Review and approve batch records, standard operating procedures (SOPs), and validation protocols.
- Manage CAPA (Corrective and Preventive Action) investigations to identify root causes and implement effective solutions.
- Facilitate cross-functional collaboration with Production and Regulatory Affairs to maintain state-of-the-art facility compliance.
- Mentor junior quality staff and promote a culture of quality-by-design across the organization.
- Oversee change control processes for complex manufacturing equipment and documentation systems.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related scientific field; Master’s preferred.
- 5+ years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- Expert-level knowledge of cGMP regulations (21 CFR Part 210/211) and ICH guidelines.
- Proven track record in managing successful regulatory inspections and agency audits.
- Exceptional analytical skills with the ability to interpret complex technical data.
- Strong interpersonal skills with the ability to influence quality standards across all levels of the business.