QA Director
Collins McNicholas
- Co Louth
- Permanent
- Full-time
- Integral part of both the Quality Leadership and Site Leadership teams, acting as a representative for the Senior Quality Director.
- Holds responsibility for overseeing all quality aspects related to the manufacturing and release processes of medicinal products.
- Leads and supervises various crucial quality functions, including the Quality Management System, Validation, Client Management, and Drug Substance Operations.
- Ensures strict adherence to standard operating procedures (SOPs), current Good Manufacturing Practices (cGMP), and regulatory standards.
- Engages in extensive collaboration with counterparts, business associates, and quality leaders within the company locally and globally.
- Collaborates with Quality colleagues and other stakeholders to address product quality issues, conduct impact assessments, and communicate effectively with Qualified Persons (QP), clients, and regulatory bodies.
- Advanced degree (Bachelor, Master, or PhD) in life sciences such as Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, etc.
- QP qualification highly desirable.
- 15-20 years in pharmaceutical quality leadership.
- Proven delivery and compliance.
- Familiarity with EMA, FDA, ICH, WHO regulations.
- Extensive biopharmaceutical experience.
- Expertise in risk management.