Associate Director Site Quality Assurance - Ireland
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- Management of the Internal Inspection Programme and Management of the External Inspection Programme (and, in conjunction with the Divisional auditing group, inspection management of raw material/ component, contract Laboratories & Manufacturers and GMP suppliers). Will also provide oversight for the training and coaching of internal auditors to drive QMS holistic reviews and continuous improvement initiatives.
- Participate and Comply with the Quality Management System (QMS) requirements, including ownership, as relevant to you.
- 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 by deploying company Six Sigma tools within the CoE Group on projects such as: Problem Solving, reducing cycle time, Lean principles within the process.
- Develop an effective, focused and strong CoE 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).
- Degree or 3rd level qualification (Science, Quality).
- QP qualification (Desirable).
- Evidence of Continuous Professional Development.
- Preference for at least a Lean Six Sigma Green Belt
- 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.
- Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc.)
- 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.
- 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.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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