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.
- The Purpose of the Quality CoE Lead is to manage and provide an independent Quality oversight over all GMP related activities on site.
- The Quality CoE Lead will provide leadership to the Quality CoE team in providing an independent Quality oversight over all GMP related activities across the site and in meeting our Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.
- The leadership style is one of collaboration, coaching and facilitating the CoE team and personnel outside the group on GMP requirements to drive a high performance organisation.
- This will require a substantial amount of his/her time within the area engaging and communicating with the CoE team members and influencing and promoting GMP Compliance across the site.
- The Quality CoE Lead is responsible for the effective and efficient running of all operations within the Quality CoE Group and promoting a stable process supported by a flexible, collaborative, multi-skilled teamwork environment.
- The CoE Lead will model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
- 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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