Excellent opportunity for a Quality Director (GMP) working for a Biologics Leader in the Northeast of Ireland. The ideal person would be a proven people manager with extensive manufacturing Quality experience in a Biologics or Pharmaceutical setting. The ideal candidate will be a Qualified Person, but this is not a pre-requisite.
Overview of your responsibilities (full job description available on request):
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 themanufacturing 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.
Knowledge, Skills and Experience Required for the Role:
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.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062