Social network you want to login/join with:Executive Director, Compliance Enabling QMS (Corporate Quality), DublinClient:Bristol Myers SquibbLocation:Dublin, IrelandJob Category:OtherEU work permit required:YesJob Reference:058d45dccc2bJob Views:2Posted:02.04.2025Expiry Date:17.05.2025Job Description:Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Position SummaryReporting to the Vice President, Corporate Quality, this role is primarily responsible for the development, management and oversight of the End-to-End Quality Management system inclusive of R&D Operations and Global Pharmaceutical Sciences driving compliance at the site and functional levels across all GxP areas covering cell therapy, biologics and small molecules. Additional ownership of core quality systems including Investigation, Deviation, CAPA Management, Change Control, Risk Management, Audit/Inspection, Training, and other quality system processes, as needed. Responsible for continuous improvement cycles related to the QMS and ensuring capabilities of the business to implement the QMS.Key ResponsibilitiesResponsible for implementing and maintaining The Quality Management System (QMS) across R&D and GPS ensuring continuous improvement for the associated Quality Systems and implementing strategy at the enterprise level.Ensures adherence to phase appropriate cGxP compliance requirements, in compliance with FDA, EU and global regulations and ICH guidelines.Effectively collaborates with sites and functions across the company to analyze and resolve issues in accordance with appropriate quality standards ensuring a fit for purpose model across the enterprise.Stay informed of evolving regulatory requirements and industry trends related to quality management systems, and proactively assess their impact on the organization. Define, enhance and maintain GPO network to drive strategic GPS objectives.Support BMS M&A activities by ensuring alignment across the QMS framework.Foster a culture of quality excellence by promoting awareness, training, and engagement across the organization, emphasizing the importance of quality in all aspects of our operations.Collaborate with senior leadership to develop and execute quality strategies that align with business objectives and drive continuous improvement in quality performance.Qualifications & ExperienceBachelor’s Degree or equivalent education and 15+ years of experience. Master’s degree preferred.Must have experience working in the pharmaceutical industry with the FDA, EMEA and preferably multiple additional regulatory agencies in other foreign countries. Experience working in Regulatory Law is a plus.Must have experience working at an enterprise level engaging with executive business leadership. Plant/site experience is also desired.Profound understanding of international GxP regulations and policies setting processes of major regulatory agencies (e.g. US FDA, EU, WHO).Quality operational experience to ensure understanding of key business quality and compliance drivers of the Pharmaceutical Industry.Strong communication, negotiation, problem solving and interpersonal skills.Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.Demonstrated change agility and leading others through change and ambiguity.Ability to provide innovative ideas or alternatives that create competitive advantages across enterprise.High organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.Demonstrated ability to work effectively in a matrix environment and drive results through "influence" as well as direct management.Demonstrated Enterprise mindset to be able to think and act across functions and divisions.
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