OverviewAssociate Director GRADS Compliance Partner, REMS and PV (Remote)Role description: This role is responsible for providing strategic and operational leadership for global PV and REMS to execute the quality framework of controls and oversight necessary to achieve compliance, inspection readiness, and continuous improvement.ResponsibilitiesProvide overall GRADS Compliance support in line with the execution of PV and REMS processes and compliance requirements, ensuring data and scientific integrity practices align with global policies and procedures.Collaborate with GRADS Compliance Operations to build and optimize the GRADS Compliance organization, providing management analysis and advice on PV and REMS, recommending quality reports, performance metrics, and best practices for continuous improvement.Serve on the extended leadership team to identify and mitigate risks, maintain a compliant state, monitor key metrics, and drive process improvement through best practices and issue resolution.Participate in GRADS Compliance Council and support reporting on KPIs and escalated topics.Stay current with health authority actions and emerging regulations in global PV and REMS; share insights with functional area leadership and assess impacts on compliance.Conduct after-action reviews with GRADS Compliance Operations and PV/REMS to drive learning and improvements after incidents.Collaborate to design strategies to pre-empt compliance issues and review vendor metrics for compliance concerns and opportunities.Support vendor governance and provide the compliance lens during data presentations; participate in due diligence as requested.Resolve global compliance or quality issues arising from partnerships; provide recommendations to management and senior leaders for CAPAs and inspections.Contribute to the development of business continuity plans for PV and REMS and guide testing and execution of business continuity activities.As a member of the GRADS Compliance Leadership team, ensure PV and REMS services enable the business as a partner of choice and drive operational performance.Present complex processes, anticipate objections, and persuade stakeholders when appropriate.Promote data and scientific integrity, effective use of systems, and proactive quality and compliance practices; foster compliance leadership across procedures.Engage Quality teams and align risk management strategies for GRADS Compliance; support inspection readiness and regulator responses as needed.Transfer PV and REMS knowledge to GRADS Compliance and stay current with industry compliance and quality trends.Qualifications8 years of R&D quality or compliance experience or relevant experience in global PV or REMS5+ years of experience communicating with senior leaders with demonstrated accountability and strong interpersonal, communication, negotiation, influencing, and problem-solving skillsAbility to work autonomously at a senior level in a matrix and team environmentTravel up to 30%Ability to communicate complex information to diverse scientific and non-scientific audiences in verbal and written formatsStrong collaboration across R&D, quality, commercial, and manufacturing organizationsCreative and innovative problem-solver capable of achieving GRADS goals in a high-quality, cost-effective mannerAbility to manage multiple complex activities simultaneously and think critically and strategicallyDemonstrated leadership values and cross-cultural collaboration experience in multi-country environmentsExcellent Microsoft Office and online collaboration tool skillsEducationB.S. in Science (or equivalent) required; advanced degree preferredEqual OpportunityJazz Pharmaceuticals is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.Compensation and Benefits (US Based Candidates)The full base pay range is $151,200.00 - $226,800.00. Compensation includes a discretionary annual bonus or incentive plan and discretionary equity grants, subject to plan terms. Benefits include medical, dental, vision, 401k, and paid time off. For more information on Benefits, please visit the Jazz Careers site.
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