Senior Quality Manager - Qualified Person, Responsible Person

​I’m representing a leading biotech in their search for a Senior Quality Manager in Ireland. A Qualified Person/Responsible person is required, as with WDA in place, this person would help establish an appropriate QMS and apply for MIA, and lead Regulatory Inspections covering GDP and GMP.

This is a permanent role with great growth prospects, as my client expands their existing portfolio and develops an incredible pipeline of Cell&Gene therapies.

Main Responsibilities

• Enhance and maintain QMS, ensuring ensure all requirements to apply for an MIA.

• Ensure WDA/MIA accurately reflect the current organisation, vary license where necessary

• Planning/ Preparation/supporting/hosting for Regulatory inspections

• Providing front and backroom inspection support

• Post-inspection follow-up with responses and CAPAs

• Manage/Approve/Assess event investigations deviations

• Monitor, assess impact, and communicate Regulatory Intelligence information

• Perform QP duties as per the GMP guidelines

• Perform RP duties as per GDP guidelines

• Create/review and approve SOPs and other Quality Documents

• Support product recalls for Ireland

• Review Product Returns from Irish Market.

Technical Skill Requirements

• Bachelor’s or Master’s degree and extensive relevant work experience in a scientific field

• Eligible to act as a Qualified Person in the EU

• Eligible to act as a Responsible Person in the EU

• Good understanding of cell and gene therapy quality area – manufacturing or testing

• Experience working in an internal biopharma development/production environment

• Experience of working in an international organisation, with international affiliates, and within a matrix environment

• Extensive experience of GDP and GMP

• The ability to lead regulatory inspections

• Ability to learn new information and roll out to the wider audience to develop their knowledge

• Ability to design technical documentation required for the role

Personal Skill Requirements

• Work cross-functionally with all levels to foster exceptional collaboration

• Ability to evaluate quality matters and make decisions utilizing a risk-based approach

• Adaptability /Flexibility

• Analytical thinking / Data Analysis/ Attention to detail

• Change Management

• Continuous Process improvement

• Strategic thinking / forward-thinking / planning

This is a full-time, permanent role, and is majority home-based, but with some time in the central Dublin office. If you have the essential skills required and would like to discuss the full detail of the Job Description, required competencies, and remuneration, please contact Katie Dunbar on +441293 584300, or apply with your CV to arrange a confidential discussion.