Job Description
Are you ready to influence the future of drug development? Nexus BioPharm Solutions is seeking a detail-oriented Senior Quality Assurance Specialist to join our elite team in the heart of the Cambridge biotech hub. In this pivotal role, you will champion quality culture, ensure global regulatory compliance, and support the life-cycle management of our cutting-edge therapeutic pipelines.
We offer a collaborative environment, competitive compensation, and the opportunity to work on treatments that truly change lives.
Responsibilities
- Lead internal and external audits to ensure adherence to cGMP and ICH guidelines.
- Manage the CAPA process, performing root cause analysis for deviations and non-conformance events.
- Review and approve batch records, standard operating procedures (SOPs), and validation protocols.
- Provide expert guidance to cross-functional teams on regulatory submissions and compliance strategies.
- Oversee vendor qualification programs and maintain the Approved Supplier List.
- Participate in pre-approval inspections (PAI) and regulatory authority interactions.
- Analyze quality metrics to identify trends and implement continuous process improvements.
Qualifications
- Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field.
- Minimum of 5-7 years of experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
- Deep understanding of FDA (21 CFR Part 210/211) and EMA regulatory requirements.
- Proven ability to lead complex investigations and write high-quality technical reports.
- Excellent communication skills with the ability to influence stakeholders at all levels.
- Strong analytical mindset with proficiency in Quality Management Systems (QMS).
- ASQ Certified Quality Auditor (CQA) or similar certification is highly desirable.