Associate Director, Quality


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

25th June 2020

Location

Dublin

Salary/Rate

£90361 - £91264

Type

Permanent

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

Global Biopharmaceutical company has ambitious plans and have an exciting opportunity for a permanent full time Senior Manager in the Project Management team based at the Dublin office.The CompanyBiopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.The company has a portfolio of medicines through its orphan, primary care and rheumatology business units. The company's global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.The PositionReporting directly to the Senior Director of Quality (Biologics)Operations, the Associate Director is part of the quality team responsible for the quality operational activities for all commercial products and bringing products through Phase 3 to commercial. The team is responsible for ensuring the highest quality standards for the product portfolios by managing the operational quality system elements of deviations, CAPAs, change controls and product complaints.The successful candidate is also responsible for leading quality operational activities for specific product(s) biologic portfolio within an assigned business unit. They will lead the representation, communication and management of quality issues with internal partners, (including but not limited to business unit, technical operations, supply chain and R&D) and external partners (including but not limited to CMOs, 3rd party laboratories and alliance partners). The successful candidate will also support and execute quality operational, strategic and team goals for their product portfolio in order to assure the highest quality standards and regulatory compliance.The Associate Director is further responsible for ensuring the highest quality standards for the product portfolios by the tracking and monitoring of batch, stability and quality control data. This Associate director serves as the analytical, technical and quality operational expert on the product portfolios within the assigned business unit.Qualifications and Skills Required:A Master's degree in a science discipline is required, with an excellent understanding of quality assurance and CMC regulatory requirements.10+ years bio-pharmaceutical experience in Quality Control and/or Quality Assurance.Qualified Person status is desirable.A strong understanding of, and experience in quality management is essential.Knowledge of QA for all biopharmaceutical dosage forms and drug substance manufacture is desirable.Competitive salary and market leading benefits package on offer with the role.For immediate consideration please reply with an up to date CV. Not sure yet? No CV ready? Please get in touch for more information. To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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