Job Description
Are you ready to elevate your career at the forefront of medical innovation? Nexus BioPharm Solutions is seeking a detail-oriented Senior Pharmaceutical Quality Assurance Specialist to join our elite team in the heart of Cambridge's biotech hub.
In this role, you will be the guardian of our production standards, ensuring our life-saving therapies meet the highest global regulatory benchmarks. You will collaborate with cross-functional teams to drive continuous improvement and maintain an uncompromising culture of quality.
Responsibilities
- Oversee and monitor GxP compliance across all manufacturing and laboratory operations.
- Conduct comprehensive internal and vendor audits to ensure adherence to FDA and EMA standards.
- Lead CAPA investigations and implement robust root-cause analysis solutions.
- Review and approve batch records, validation protocols, and technical reports for accuracy.
- Support regulatory inspections and provide expert technical documentation.
- Mentor junior quality staff and foster a culture of quality-by-design.
- Analyze quality metrics to identify trends and process improvement opportunities.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related scientific field.
- Minimum 5-7 years of experience in QA within a regulated pharmaceutical or biotech environment.
- Deep understanding of cGMP regulations and ICH guidelines.
- Proven ability to manage complex documentation systems and electronic quality management systems (eQMS).
- Exceptional analytical thinking and problem-solving abilities.
- Strong communication skills, capable of influencing stakeholders at all levels.
- ASQ Certification or similar quality industry credentials are highly preferred.