Did you know that your Internet Explorer is out of date?
To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.
Google Chrome |
Internet Explorer |
Mozilla Firefox |
Opera |
Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job
Details
QA Director of Operations
Reference: | SCA013363 | Location: |
Louth |
Qualification: | Degree | Experience: | 10+ Years |
Job Type: | Permanent | Salary: | Not Disclosed |
May be suitable for:
QA Director, QA Manager, QA Specialist, QA Supervisor, Qualified Person, Quality Director, Quality Manager, Quality Specialist
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
- 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
Group sites:
Medical Affairs Jobs |
Engineering Jobs |
Chemistry Jobs |
Clinical Research Jobs |
Scientific Jobs |
Science Jobs |
Biopharmaceutical Jobs |
Quality Assurance Jobs |
Contract Jobs |
Supply Chain Jobs |
Pharmaceutical Jobs |
Connected Health Jobs |
Medical Device Jobs |
Biotechnology Jobs |
Diagnostics Jobs |
Pharmaceutical | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy visit Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS
Pharmaceutical | Tel:+353 1 685 4545 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy visit Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 |
Web Design / SEO by WebScience | Valid XHTML - CSS