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. 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. Due to continued expansion, an exciting new position has arisen in the organisation for a Director of Quality with a remit covering two manufacturing plants including of CMO management.
- Maintaining and protecting detailed knowledge of the product and process at both the API and manufacturing sites.
- Direct oversight of Quality for products at the manufacturing and testing CMO’s.
- The commercial release of products, including batch record review and the assessment of associated deviations, changes and other issues as they arise.
- QP release of products.
- Leading and/or supporting investigations and ensuring on-time completion of all corrective action items assigned to the area.
- Managing the Stability Program including tracking sample pull dates, receipt of COAs from vendors, review. and approval of stability protocols, stability data, etc.
- The management of compliance for products and interaction with relevant internal regulatory personnel.
- Assisting in generating and reviewing CMC sections of NDAs, sNDAs, INDs, Annual Product Reports for filing with the FDA.
- Assisting in generating and reviewing CMC sections of submissions for other regulatory authorities as required.
- Supporting regulatory inspections and audits for the group and assisting CMO’s as needed during regulatory inspections and audits at their sites.
- Assisting Product Monitoring group in management of drug product complaints, FAR’s, recalls etc as required.
- Manage Quality aspects for API plant currently under construction.
- Accountability and responsibility for any process or product changes and leading efforts and ideas to completion.
- Setting clear vision by ensuring goals and objectives for the Quality group are aligned with corporate strategies and managing each team member’s performance management.
- B.Sc in chemistry or related science minimum
- Qualified Person status
- 10-15 years related Pharmaceutical experience (both API & Drug Product)
- 10+ year’s experience in a managerial role;
- Expert knowledge of cGMP requirements
- At least 2 year’s experience as releasing QP
- Expertise in the manufacture and control of finished sterile injectable products and/or biological products.
- Strong working knowledge of FDA and EU requirements and guidance documents
To learn more apply online or contact Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin City Centre