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 the Kendall Square biotech hub. We are seeking a meticulous and driven Quality Assurance Specialist to ensure our manufacturing processes meet the highest global standards of safety, efficacy, and compliance.
You will work alongside elite research and development teams to foster a culture of quality, providing oversight that directly impacts patient outcomes. If you are passionate about life sciences and excel in a fast-paced, regulated environment, we want to hear from you.
Responsibilities
- Oversee and monitor compliance with cGMP, FDA, and EMA regulatory requirements across production lines.
- Lead internal and external quality audits, providing actionable insights for process improvement.
- Manage Deviations, CAPA, and Change Control processes to ensure organizational adherence to protocols.
- Review and approve batch production records, analytical testing data, and stability reports.
- Collaborate with cross-functional teams to resolve quality issues and implement corrective measures effectively.
- Maintain and update Quality Management System (QMS) documentation and SOPs.
- Participate in risk assessment activities, including FMEA, to proactively identify and mitigate product risks.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 5-7 years of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry.
- Deep understanding of 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex investigations and technical documentation.
- Strong analytical skills with proficiency in data-driven quality metrics.
- Excellent communication skills with the ability to influence stakeholders at all levels.
- Professional certification (e.g., ASQ CQA or CMQ/OE) is highly desirable.