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.
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