Job Description
Are you ready to shape the future of medicine? Nexus BioPharm is seeking a detail-oriented Senior Pharmaceutical Quality Assurance Specialist to join our elite team in the heart of the Cambridge biotech hub. You will play a pivotal role in ensuring our drug development processes meet the highest global standards, directly impacting patient outcomes worldwide.
We foster a culture of scientific integrity, innovation, and career growth. If you are passionate about compliance and continuous improvement in a fast-paced environment, we want to hear from you.
Responsibilities
- Lead internal audits and support external regulatory inspections (FDA/EMA).
- Review and approve batch production records, analytical data, and validation protocols.
- Manage the CAPA (Corrective and Preventive Actions) lifecycle from initiation to closure.
- Drive quality risk management initiatives across clinical and commercial manufacturing stages.
- Collaborate with cross-functional teams to investigate deviations and perform root cause analysis.
- Ensure strict adherence to cGMP guidelines and standard operating procedures (SOPs).
- Mentor junior quality staff and contribute to departmental process optimization projects.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum 5+ years of experience in QA/QC within a pharmaceutical or biopharmaceutical environment.
- Deep understanding of FDA 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex investigations and technical documentation.
- Strong analytical mindset with excellent verbal and written communication skills.
- Professional certification (e.g., ASQ Certified Quality Auditor) is highly preferred.
- Exceptional organizational skills with a keen eye for regulatory detail.