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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

QA Director of Operations


Reference:SCA013363 Location: Louth
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

QA Director of Operations
Our client, a global biologics organisation are currently recruiting for a QA Director of Operations to join their team on a permanent basis. The QA Director will direct quality oversight of products manufactured and tested on site, from introduction through to product release. As QA Director, you will be responsible for all aspects of Quality activities associated with daily operations and future site and global strategic design. The QA Director will proactively identify and minimize product quality and compliance risks by establishing a Quality strategic plan, while developing and embedding Quality Standards, Policies and Culture.

Responsibilities

  • Key member of the Quality Leadership and Site Leadership Team. Be a strong delegate for the Senior Quality Director
  • Responsible for all aspects of quality associated with the manufacturing and release of medicinal products
  • Lead and manage multiple key quality functions including the Quality Management System, Quality Qualification & Validation, Quality Client Management & Quality Drug Substance Operations
  • Accountable for oversight of activities to ensure compliance to SOPs, cGMP and CMC regulatory requirements as well as acting as a Quality advocate for the Quality Department
  • Liaise with counterparts, business, and quality leaders across both locally and globally
  • Partner with Quality colleagues and other business stakeholders to provide leadership and direction on product quality investigations, critically assess and support impact assessments where needed and liaise with QP, Client and/or CMC regulatory affairs with regard to mitigations such as change controls, variations etc
  • Develop and implement the strategic objectives for the Quality organisation inclusive of headcount management, and budget design at both the local and global level
  • Build and develop a high performing Quality management team, including attracting and maintaining a strong talent pipeline
  • Accountable for Quality Organisational design, to ensure optimum structure to achieve quality compliance.
  • Work with the Senior Quality Director to ensure accurate, relevant reliability and metrics are in place as key Quality performance indicators
  • Ensure that site’s quality standards, practices, procedures, and documentations are in accordance with cGMP regulations, pharmacopoeia, and corporate global, regional, & the site requirements, industry standards and best practices
  • Support the culture of Quality on site and drive improvements in all areas of compliance and setting expectations and standards for adherence. Create a culture of audit readiness
  • Key leader in ensuring regulatory compliance and achievement of licences associated with manufacturing of bioproducts. Establish site strategy to ensure continuous compliance to regulatory and client expectations
  • Drive quality system development, establishment, and improvement for the site
  • Ensure the engagement of the Quality Assurance organization with Learning and Development initiatives and the performance management system for the site
  • Ensure adherence to all safety and quality standards
Requirements
  • Advanced degree (Bachelor, Master, or PhD) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or other life science related fields.
  • QP Qualified Highly Desirable
  • At least 15–20 years relevant work experience in quality and leadership experiences in biopharmaceutical/pharmaceutical industry
  • Demonstrated examples of deliverance and compliance success
  • Must be familiar with EMA & FDA regulations; ICH and WHO guidelines
  • Proven risk management – Identification and Control
For more information please contact Sinéad Cullen on +353879500821