Associate Director, Quality
- 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).
- 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.
Apply for Associate Director, Quality
Already uploaded your CV? Sign in to apply instantly