Associate Director, Quality

Location
Cork
Salary
Competitive
Posted
18 May 2017
Closes
15 June 2017
Position / level
Director, Professional
Contract Type
Permanent
Hours
Full Time

Responsibilities

  • Comply with the Quality Management System (QMS) requirements. 
  • Co-ordination of inspections by Divisional Auditing Group and Regulatory Bodies. 
  • Review & approval of GMP procedures and associated documents 
  • Continuous improvement of systems & procedures on site, to ensure compliance with the most up to date cGMPs 
  • Drive the implementation of integrated Quality Risk Management at the site. 
  • Manage generation & review of quality compliance metrics and provide appropriate governance through functional unit team review and monthly Site Quality Council (SQC) reviews 
  • Provide oversight and coaching for the Quality aspects of Supplier Management. 
  • Manage Quality Management System (QMS) core requirements, policies, procedures & guidelines compliance 
  • Provide Quality support to engineering commissioning, system qualification & process validation projects & schedules. Support to include providing quality input into validation project approach, protocol & report review and approvals. 
  • Co-ordination of the area resources to deliver a quality and efficient support service & development of area personnel and provision for succession & delivery of area performance to meet or exceed performance and quality goals. 
  • Control of area expenditure within budgetary limits & contribute to site management operational and strategic initiatives.
  • Responsible for driving a culture of Continuous Improvement
  • Develop an effective, focused and strong team by understanding each person's abilities, unique contribution and broadening their skill set to be agile and prepared for any future business requirements. 
  • Provide the team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma). 

Responsibilities

  • BSc in relevant area. 
  • At least 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality function. 
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc.) 
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies 
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to a manufacturing operation.
  • Demonstrated leadership and change management skills with a continuous improvement focus. 
  • QP qualification (Desirable). 
  • Evidence of Continuous Professional Development. 
  • Proven track record of delivering high performance through development and coaching of a team. 
  • Process and technology background: the successful candidate will fully understand how to drive optimization, OEE and commissioning. 
  • Demonstrated ability in holding team members accountable for results and managing performance. 
  • Demonstrated ability to fully realize improvement initiatives. 
  • Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, PITs etc. 
  • Advanced PC skills such as Excel, Word, PowerPoint. 

If you are interested in finding out more about this role or to submit your application, please click APPLY.