|Salary:||£€85,000-€100,000 DOE plus great bonus, shares and benefits package|
|Contact name:||Katie Dunbar|
|Published:||29 days ago|
|Expiry date:||24 October 2021|
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.
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
Analytical thinking / Data Analysis/ Attention to detail
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.
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