Job Description
Are you ready to elevate your career at the forefront of medical innovation? Nexus BioPharm Solutions is seeking a detail-oriented Senior QA Specialist to join our elite clinical development team in Cambridge. You will play a pivotal role in ensuring our life-saving therapies meet the highest global regulatory standards, safeguarding patient health while driving operational excellence.
We offer a collaborative culture, cutting-edge facilities, and a commitment to professional growth.
Responsibilities
- Oversee and manage comprehensive GxP quality systems to ensure total regulatory compliance.
- Conduct internal and external audits to identify process gaps and implement robust corrective actions (CAPA).
- Review and approve batch production records, analytical data, and validation protocols.
- Collaborate with cross-functional R&D teams to streamline documentation and compliance procedures.
- Lead vendor qualification programs to maintain high standards across the supply chain.
- Serve as the primary point of contact for regulatory agency inspections and inquiries.
- Draft and update Standard Operating Procedures (SOPs) to align with evolving FDA and EMA guidelines.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related Life Science discipline.
- Minimum of 5-7 years of direct experience in Pharmaceutical Quality Assurance.
- Deep understanding of 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex investigations and root cause analysis.
- Strong interpersonal skills with the ability to influence stakeholders at all levels.
- Professional certification (e.g., ASQ CQA or CQE) is highly preferred.
- Exceptional technical writing and documentation proficiency.