Job Description
Are you ready to shape the future of medicine? Nexus BioPharm Solutions is at the forefront of innovative drug development, and we are seeking a detail-oriented Senior QA Specialist to join our elite team in Cambridge. In this role, you will be the guardian of our clinical integrity, ensuring our life-saving therapies meet the highest global regulatory standards.
We offer a dynamic, high-growth environment where your expertise directly impacts patient outcomes. If you are passionate about compliance, process improvement, and cross-functional leadership, this is the career-defining move you have been waiting for.
Responsibilities
- Lead internal and external audits to ensure compliance with cGMP and FDA guidelines.
- Manage the deviation and CAPA processes, ensuring robust root cause analysis.
- Review and approve Master Batch Records (MBR) and Standard Operating Procedures (SOPs).
- Collaborate with R&D and Manufacturing teams to implement quality-by-design principles.
- Provide QA oversight for clinical trial materials and pharmaceutical stability studies.
- Maintain compliance documentation for regulatory submissions and annual product reviews.
- Mentor junior quality staff to foster a culture of quality excellence across the organization.
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Pharmacy, Biology, or a related field.
- Minimum of 5-7 years of experience in pharmaceutical Quality Assurance.
- Deep working knowledge of 21 CFR Part 210/211 and ICH guidelines.
- Strong analytical mindset with the ability to lead complex investigations.
- Professional certification (e.g., ASQ CQA or CMQ/OE) is highly preferred.
- Exceptional verbal and written communication skills for regulatory communication.
- Proven ability to navigate high-pressure deadlines in a fast-paced biotech environment.