Haleon Dungarvan, County Waterford, IrelandHaleon is recruiting for a Senior Quality position on site acting as an independent advisor to the Site Director and the Senior Leadership Team (SLT) regarding Quality and Compliance.This position has management responsibility for Quality Assurance and Quality Control for the manufacturing facility producing Medicinals, Medical Devices, and intermediate bulk products with worldwide distribution.The role is responsible for the oversight of the Quality function by providing direction and managing the Quality team:Ensuring that appropriate quality systems are implemented and actively maintained in place and in useInfluencing operational and production facility design, supplier management and site strategiesDriving the site Quality culture to ensure that the site meets all relevant cGMP requirementsIn this role, a close collaboration is essential with the Site director and all functions in the Site leadership team, to operate in a cross functional and cost-effective manner and foster continuous improvement and implementation of best practices.Responsibilities:Provide direction and support for product quality and compliance matters - Direct all quality related functions for the manufacturing facility, including commercial product releaseEnsure implementation of Consumer Healthcare Quality standards and current GMP requirements within the site Manufacturing plantDeploy Quality and Compliance systems (HQS) and ensure they are in place and in use.Develop continuous improvement practices.Keep the site ready for external Health Authority inspections and monitor the site inspection readiness status. Manage inspections and audits.Guarantee corrective and preventative actions are completed as per committed timelines and are effective.Evaluate and follow up on the appropriateness and completeness of corrective action plans until closure.Escalate site major quality related topics using the real time escalation system – Proactively identify and manage the site quality and compliance risks, using the Consumer Health Risk Management System (RMS) and adequate governance.Monitor Key Quality Performance Indicators for the site. Identify trends and use the Site Quality council to define quality improvement plans.Investigate quality issues using applicable root cause analysis and problem-solving methods to avoid repeat deviations.Implement Right First-Time principles for continuous improvement across compliance systems and process operations by creating of high performing work teams and attaining compliance and customer service objectives.Lead and provide quality expertise assessment for sourcing and business development initiatives to ensure selections adhere to current quality / compliance guidelines. Drive the site Quality culture, and ensure all functions have the capabilities to work in a pharmaceutical environment.Be an instrumental member of the site leadership team, to actively influence the site strategy and execution of the site Quality plan.Develop a strong site Quality team, with capabilities to take quality decisions.Build a strong pipeline of talents.Provide leadership to the site Quality team and ensure succession planning. Ensure assigned projects are executed in a timely manner and with the expected quality.Required Skills Sets & Experience:Bachelor's/Master’s degree in chemistry, pharmacy, Biology or Related scienceAbility to manage stakeholders, make independent quality decisions and stand for quality5 years relevant experience in a regulated pharmaceutical industry in the area of manufacturing and qualityProfessional experience in QA, GMPs, in the pharmaceutical field, Quality Systems and OperationsExcellent communication, planning and organization skills.Good knowledge of analytical laboratory activities.Knowledgeable in auditing and inspection against regulatory / quality standards.Excellent interpersonal and leadership skills, managing people and stakeholders, driving cross functional improvement projects and executing corporate programs.At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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