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, MA. In this role, you will play a critical part in ensuring our life-saving pharmaceutical products meet the highest standards of safety, efficacy, and regulatory compliance.
You will collaborate with cross-functional teams in a high-growth environment, utilizing cutting-edge quality management systems to drive continuous improvement and excellence in manufacturing processes.
Responsibilities
- Oversee and maintain the Quality Management System (QMS) in alignment with current cGMP and FDA requirements.
- Lead internal and external audits, ensuring comprehensive documentation and timely resolution of findings.
- Manage the CAPA process, conducting root cause analysis for deviations and implementing effective corrective actions.
- Provide expert guidance on quality assurance protocols for sterile manufacturing and laboratory testing.
- Collaborate with Regulatory Affairs to support product lifecycle management and submission documentation.
- Mentor junior quality staff to foster a culture of quality-first thinking throughout the organization.
- Perform thorough review and approval of batch production records and associated quality documentation.
Qualifications
- Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field.
- Minimum of 5-7 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
- Deep understanding of FDA 21 CFR Part 210/211 and ICH guidelines.
- Proven ability to manage complex quality investigations and CAPA implementations.
- Exceptional analytical skills with an uncompromising attention to detail and data integrity.
- Strong interpersonal skills with the ability to communicate technical quality concepts to non-technical stakeholders.
- Industry certifications such as CQA or Six Sigma Green/Black Belt are highly desirable.