Quality Assurance Director
|Job Title:||Quality Assurance Director|
|Contact Name:||Gerry Kennedy|
|Job Published:||almost 2 years ago|
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research, and a senior management level appointment in Quality Assurance
Reporting to Senior Director Quality, the Director Quality Assurance will manage teams in Q.A. based in Dublin, while working closely with colleagues in USA and UK. The quality unit consists of Quality Control, and Quality Assurance.
? Ensure that best practice quality improvement programmes for the sites.
? Direct and manage Quality staff to implement quality programmes and control raw material receipt, work in progress and finished product release in line with best practice and regulatory requirements.
? Ensure that appropriate quality KPIs are reported from the sites.
? Ensure that the sites are effective in the management of Quality Laboratories, Quality Assurance and Compliance functions while providing support and direction to those charged with the management of same.
? Ensure that the site quality group have a good business model but are also correctly resourced for headcount.
? Ensure adherence to quality policies and corporate procedures through internal audits.
? Maintain quality and regulatory compliance at the sites and ensure there are no significant regulatory agency citations.
? Ensure that product quality reviews are completed such as annual report and annual product reviews.
? Ensure that changes to the product manufacturing and supply chain process are implemented to the requisite quality standard.
? Liaise with US and EU agencies on GMP and GCP quality issues such as FDA, EMA, DEA.
? Maintain the Quality systems in any contracted aseptic manufacturing sites.
? Ensure the site CAPA systems are in place and atypical trends reported.
? Develop the Quality group through the initiation of programmes which include projects designed to improve overall product quality.
? Pursue qualification and validation programmes through the establishment of appropriate protocols.
? Ensure that GMP, GCP and quality audits of the sites and facilities are conducted on a routine basis and those corrective actions are closely managed and implemented. Allow audit resources available to CCO from time to time.
o Ensure awareness with new developments in quality practice and promote same across the site.
o Total quality budget over $TBD dollars.
o Have three or more direct reports.
o Travel to company sites, clients and partners on frequent basis.( 40%)
o Roll out automated GMP systems such as Electronic documentation management systems to the sites.
Ensure overall qualification of IT systems if GMP applies.
Person Spec :
Preferred candidates will be educated to Masters or PhD level in a science discipline while having an excellent understanding of quality protocols. The preferred candidate will have held a Head of site Quality position, and will ideally have 12 years + Quality Management experience across a wide range of pharmaceutical and biopharmaceutical secondary operations.
Excellent understanding of quality / regulatory principles as they apply to the industry.
Proven track record in people management and development
Logical and problem solving skills
High level of customer orientation/understanding
Strong interpersonal skills
Other Skills, Personal Competencies:
? Demonstrated alignment with company values and culture, including strong collaboration.
? Superior communications skills (written and oral).
? Project management.
? Working in multi-disciplinary, multi-site, multi-cultural/international teams.
? Strategic planning.
? Financial management.
Cv to firstname.lastname@example.org 01 2302400 www.rftgroup.ie