Job Description
Are you ready to elevate 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. In this role, you will be the guardian of our manufacturing excellence, ensuring that life-changing therapies reach patients with the highest standards of safety and efficacy.
We offer a collaborative culture that values intellectual curiosity, rigorous scientific standards, and a passion for patient health. You will work in a state-of-the-art facility, partnering with cross-functional teams to drive continuous improvement in our global regulatory compliance.
Responsibilities
- Oversee and monitor GMP compliance throughout all stages of pharmaceutical manufacturing.
- Review and approve batch records, deviations, and CAPA investigations to ensure product integrity.
- Lead internal and external audits, coordinating closely with regulatory bodies like the FDA and EMA.
- Draft, revise, and implement Standard Operating Procedures (SOPs) to streamline quality protocols.
- Provide expert guidance on quality systems, change controls, and risk management strategies.
- Collaborate with R&D and Clinical Operations to integrate quality-by-design principles into new product pipelines.
- Mentor junior quality staff and foster a culture of quality-first thinking across the organization.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 5-7 years of direct Quality Assurance experience within the pharmaceutical or biotech industry.
- In-depth knowledge of 21 CFR Part 210/211, ICH guidelines, and global regulatory requirements.
- Proven ability to manage complex investigations and lead cross-functional root cause analysis teams.
- Exceptional attention to detail and ability to interpret technical documentation with precision.
- Strong interpersonal skills with the ability to communicate quality standards to diverse stakeholders.
- Industry certification (e.g., ASQ CQA or CQE) is considered a significant advantage.