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Quality Assurance Manager

Reference:ASGM-865711
Location: Cork
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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Quality Assurance Manager
Our client, a global biologics organisation, requires a Quality Assurance Manager to join their team on a permanent basis. The QA Manager will be responsible for setting quality standards in respect of manufacturing and engineering systems and monitoring compliance with those standards.

Responsibilities
• Lead the activities of the Quality Assurance Department including documentation management and activities related to material release
• Manage several quality systems including investigations, corrective actions and change control
• Responsible for appropriately staffing and developing the Quality Assurance organization to meet business needs
• Provide leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met
• Give operational direction to the QA group in the execution of their duties
• Provide coaching, mentoring, and direction to Quality Assurance staff as appropriate

Requirements
• Advanced degree required in a scientific or engineering discipline
• 5-10 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry
• 5 years’ experience in a supporting functional area (e.g. R&D, Manufacturing, Engineering, EHS, Technical Services) is desirable
• Experience in a Quality leadership role required
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position
• Eligible for inclusion on the site manufacturing licence as Qualified Person
• Proven success in managing in a global organization



If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252




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