This company is one of the world's leading pharmaceutical companies. Through acquisitions and mergers, this company has expanded rapidly in its short history and now boasts more than 10,000 employees, and offices in more than 40 countries globally. This organisations growth strategy is to focus on developing and marketing innovative speciality medicines for symptomatic conditions to meet significant unmet patient needs. Their strategic priorities are to drive optimum performance of their existing products, enabling access to these medicines for patients today and building their pipeline through research and development and business development delivering access in the future for patients. HRM has been exclusively retained to manage a search for an exciting new position which has arisen in the organisation for a Senior Quality Manager & QP for the organisations International External Operations reporting directly to the Senior Director in the U.S.
- Act is the Qualified Person for the EU
- Ensure all cGMP/cGDP and WDA/MIA requirements are fulfilled for the supply of products (medicinal products for human use) in accordance with respective country requirements
- Manage the process that develops, establishes, and maintains quality assurance programs, policies, process, procedures and controls ensuring that performance and quality of finished products (medicinal products for human use) in accordance with Good Distribution Practices requirements
- Identify, develop and execute quality plans and project timelines to meet group, site and company goals
- Oversee quality activities related to the distributors and distribution center (receipt, storage, re-labeling (where applicable), distribution, returns,)
- Manage the quality activities related to quality agreements and other customer requests
- Lead strategic quality efforts for projects identified by the business unit/region
- Participate represent in audits and respond to audit observations
- Serves as auditor for supplier quality / CMO audits and internal audits
- Lead/Host regulatory inspection and respond to inspection observations
- Interact with corporate support groups to drive quality programs
- Complete technical and other quality duties as assigned
- Responsible for maintaining and/or leading current applicable licensing
- Review and maintain quality agreements with manufacturers and external contract services
- Responsible and accountable for budget forecasting and management of the department cost center
- BA/BS/MS in scientific field of study.
- Minimum of 7+ years pharmaceutical experience with an emphasis in Quality or a Quality related function based at either a manufacturing plant or alternatively in a virtual Quality role.
- Eligibility to act as a Qualified Person.
- Previous direct line management experience is preferential.
- Experience with exFDA regulatory agencies.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 632 1865 for a confidential discussion.