Associate Director GRADS Compliance Partner, REMS and PV (Remote)

Job Description

If you are a current Jazz employee please apply via the Internal Career site.

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Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to \ntransform the lives of patients and their families. We are dedicated to developing \nlife-changing medicines for people with serious diseases — often with limited or no \ntherapeutic options. We have a diverse portfolio of marketed medicines, including leading \ntherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. \nOur patient-focused and science-driven approach powers pioneering research and development \nadvancements across our robust pipeline of innovative therapeutics in oncology and \nneuroscience. Jazz is headquartered in Dublin, Ireland with research and development \nlaboratories, manufacturing facilities and employees in multiple countries committed to \nserving patients worldwide. Please visit\nwww.jazzpharmaceuticals.com\nfor more information.

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Brief 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.

Essential Functions / Responsibilities

• Provide overall GRADS Compliance support in line with the execution of PV and REMS processes and compliance requirements, while ensuring data and scientific integrity practices are followed and consistent with global policies and procedures.
• Work collaboratively with GRADS Compliance Operations to support the build and optimization of the GRADS Compliance organization. Activities include providing management analysis and advice on situations (existing or future state) for PV and REMS organizations.  Offer recommendations on quality reports, performance metrics, and act as a key advisor on methodologies and tools used to achieve continuous improvement.
• Sit on the extended leadership team of organizations supported to identify and mitigate risks, provide oversight to maintain a compliant state, monitor and influence key contributing metrics.  Assist to improve and simplify processes (via BPO network) and introduce best practices for quality and compliance and identifies process gaps and facilitates resolutions congruent with industry best practices.
• Participate in GRADS Compliance Council and support business to report on KPIs and escalated topics
• Stay current with health authority actions and emerging regulations in global PV and REMS and share insights and advice with functional area leadership team and review impacts on compliance.
• Conduct after action reviews jointly with GRADS Compliance Operations with PV and REMS functional areas to learn and improve after any compliance incident.
• Collaborate with GRADS Compliance Process and Training to design a strategy to pre-empt compliance issues.
• Partner with GRADS Compliance Operations and GRADS Alliance Management to review metrics of vendors for compliance concerns and opportunities.
• Participate along with GRADS Compliance Operations in Vendor Governance meetings led by GRADS Alliance Management and provide the functional area compliance lens in assessing data presented.
• Participate in GRADS Alliance Management due diligence teams GRADS-wide Compliance as requested.
• Partner with key stakeholders to resolve any global compliance or quality issues resulting from executed partnerships.
• Partner with GRADS Compliance Operations to participate in the compliance analysis in complex situations and provides recommendations to management and senior leaders in support of CAPAs, commitments, and inspections.
• Partner with PV and REMS to assist in the development of those area’s business continuity plans and provide guidance and leadership with future testing and execution of BCP as needed.
• As a member of the GRADS Compliance Leadership team, responsible and accountable to make the quality and compliance of PV and REMS services such that these processes become enablers to the business and become a partner of choice.
• Apply business and management expertise to drive operational performance across the organization.
• Present complex processes, anticipate potential objections, and persuade others to adopt a different point of view if appropriate.
• Act as an anchor to the commitment to data and scientific integrity, the efficient and effective use of systems, and driving quality & compliance proactively.
• In conjunction with global PV and REMS Leaders, foster compliance leadership across procedures and processes, employing compliance oversight with reference to regulations as required.
• Effectively engage Quality teams and support GRADS Compliance partner-aligned risk management strategies, plans, and processes.
• Support Compliance Operations in inspection efforts and developing responses to regulator questions as required.
• Responsible for PV and REMS knowledge transfer to GRADS Compliance and maintaining a current knowledge of industry compliance and quality trends.
• Contribute to determining solutions outside of current responsibilities as needed and manages day-to-day operational issues outside of current responsibilities as needed.

Required Knowledge, Skills, and Abilities

Required / Preferred Education and Licenses

Jazz Pharmaceuticals is an equal opportunity / affirmative action employer and 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.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is : $151,200.00 - $226,800.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here :