Job Description
Are you ready to influence the future of drug development? At Nexus BioPharm, we are pushing the boundaries of medicinal chemistry and clinical excellence. We are seeking a meticulous and driven Senior QA Specialist to ensure our cutting-edge pipelines meet the highest global regulatory standards.
You will work at the intersection of innovation and compliance, playing a pivotal role in bringing life-changing therapies to market.
Responsibilities
- Oversee end-to-end Quality Assurance processes for clinical and commercial drug manufacturing.
- Conduct internal and vendor audits to ensure strict adherence to cGMP and FDA guidelines.
- Manage Deviations, CAPA, and Change Control processes with precision and speed.
- Collaborate with cross-functional R&D teams to streamline documentation and validation protocols.
- Perform batch record reviews and final release authorization for pharmaceutical products.
- Lead investigation teams for quality-related issues to determine root causes and implement effective solutions.
- Represent Quality Assurance during regulatory inspections and third-party assessments.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 5 years of professional experience in Pharmaceutical QA/QC environments.
- Deep understanding of FDA, EMA, and ICH regulatory requirements.
- Proven ability to manage complex CAPA investigations and risk assessment processes.
- Excellent communication skills with the ability to influence stakeholders at all levels.
- Proficiency in electronic Quality Management Systems (eQMS) such as TrackWise or Veeva.
- ASQ Certification or relevant industry certifications are highly preferred.