Senior Quality Manager - (Trainee) Qualified Person

Location Ireland
Discipline: Quality Assurance
Job type: Permanent
Contact name: Katie Dunbar

Contact email: katie.dunbar@rbwconsulting.com
Job ref: 22107
Published: about 2 years ago
Expiry date: 28 Apr 2022 11:59

I’m representing a leading biotech in their search for a Senior Quality Manager in Ireland. A Qualified Person is required, as with WDA in place, this person would help establish an appropriate QMS and apply for IMP MIA, and lead Regulatory Inspections covering GMP. Please note, trainee QPs can be considered and will be supported as they develop to QP.


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


Main Responsibilities

  • Enhance and maintain QMS, ensuring ensure all requirements to apply for an IMP MIA.
  • Act as a Qualified Person or training to do so
  • 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
  • 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 pharma/biotech
  • Eligible to work as a Qualified Person in EU or currently in the process of QP training.
  • ATMP experience is desirable.
  • In-depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing.
  • Experience of continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools
  • Demonstrated ability to work independently to provide QA advice for large, multifaceted projects.
  • Demonstrated ability to evaluate quality matters and make complex decisions
  • Strong experience successfully leading deviations/ event investigations, Root Cause Analysis (RCA), and CAPA.
  • Strong experience with electronic document management systems


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.