2 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Blackfield Associates
Lead Quality Assurance Consultant - United Kingdom & Ireland
Blackfield are partnered a leading organisation in the pharmaceutical and healthcare services sector, is seeking a
Quality Director – Responsible Person
based in Dublin.
The Quality Director will hold primary responsibility for the development, implementation, and ongoing maintenance of the Quality Management System, ensuring full compliance with Good Distribution Practice, Good Manufacturing Practice, and applicable regulatory requirements.
This role is pivotal in maintaining the organisation's Wholesale Distribution Authorisation and ensuring adherence to obligations as a Marketing Authorisation Holder.
The Quality Director will also oversee Pharmacovigilance activities, Regulatory Affairs, and Advertising compliance, ensuring robust systems and processes are in place to manage safety data, regulatory submissions, and promotional material reviews.
The role involves cross-functional collaboration with internal stakeholders and external partners, ensuring end-to-end compliance across all product-related activities.
Key Responsibilities
Responsible Person & Regulatory Compliance Oversight:
Serve as the designated Responsible Person, ensuring the organisation meets all obligations under its Wholesale Distribution Authorisation, with full compliance to Good Distribution Practice, Good Manufacturing Practice, Medical Device regulations, and Marketing Authorisation Holder responsibilities.
Quality Management System Leadership:
Lead the development, implementation, and continuous improvement of the Quality Management System, including quality agreements, audits, deviation management, corrective and preventive actions, change control, and inspection readiness.
Pharmacovigilance & Regulatory Affairs Management:
Oversee Pharmacovigilance operations ensuring compliance with global safety reporting obligations; manage Regulatory Affairs activities including product licensing, variations, labelling, submissions, and promotional compliance aligned with regulatory expectations.
Cross-functional Collaboration & Team Leadership:
Lead and develop the Quality team, foster collaboration with Supply Chain, Commercial, and Regulatory Affairs functions, manage external partners/vendors, and act as subject matter expert on Exempt Medicinal Products, driving process improvements and operational excellence.
The successful candidate will have three to five years of experience in a regulated pharmaceutical environment, with proven expertise in Pharmacovigilance operations, Regulatory Affairs, and distribution compliance.
Prior experience as a Responsible Person under a Wholesale Distribution Authorisation is essential.
A strong understanding of Good Distribution Practice and Marketing Authorisation Holder responsibilities is required, along with experience managing safety data, regulatory submissions, and promotional compliance.
A Bachelor's degree in a scientific or healthcare discipline is preferred.
If you are interested in this opportunity, please send your up-to-date CV to or call Oliver on 02392 314 792.
Seniority level
Seniority level
Director
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Transportation, Logistics, Supply Chain and Storage
Referrals increase your chances of interviewing at Blackfield Associates by 2x
Sign in to set job alerts for "Director of Quality" roles.
Dublin, County Dublin, Ireland 3 weeks ago
Associate Director, External Service Provider QA
Dublin, County Dublin, Ireland 5 days ago
Director, Global Operations Communications
Dublin, County Dublin, Ireland 3 days ago
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 3 months ago
Dublin, County Dublin, Ireland 3 months ago
Dublin, County Dublin, Ireland 3 months ago
Clinical Quality Assurance – Program Lead
Dublin, County Dublin, Ireland 6 days ago
Blanchardstown, Fingal, Ireland 1 week ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 4 days ago
Dublin, County Dublin, Ireland 1 week ago
Associate Director, Medical Governance & Risk Management
Dublin, County Dublin, Ireland 3 days ago
Director of Business Planning & Analysis (Medical Affairs and Quality)
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 3 weeks ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 1 week ago
Project Director (Associate Director) - Rail
Naas, County Kildare, Ireland 2 weeks ago
Project Director (Associate Director) - Rail
Project Director (Associate Director) - Rail
Naas, County Kildare, Ireland 2 months ago
Director of Safe and Inclusive Programming
Dublin, County Dublin, Ireland 2 weeks ago
Dublin, County Dublin, Ireland 1 week ago
Dublin, County Dublin, Ireland 1 week ago
Dublin 6, County Dublin, Ireland 14 hours ago
Broomfield, County Wicklow, Ireland 6 days ago
We're unlocking community knowledge in a new way.
Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr