Overview

Associate Director GRADS Compliance Partner, REMS and PV (Remote) at Jazz Pharmaceuticals. This role provides 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.

Responsibilities

• Provide overall GRADS Compliance support in line with the execution of PV and REMS processes and compliance requirements, ensuring data and scientific integrity practices follow global policies and procedures.
• Collaborate with GRADS Compliance Operations to support the build and optimization of the GRADS Compliance organization; offer management analysis and advice on PV and REMS current or future state, recommendations on quality reports and performance metrics, and guidance on methodologies and tools for continuous improvement.
• Sit on the extended leadership team of supported organizations to identify and mitigate risks, maintain a compliant state, monitor key metrics, and introduce best practices for quality and compliance; identify gaps and facilitate resolutions in line with industry best practices.
• Participate in GRADS Compliance Council and support the business in reporting 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 review impacts on compliance.
• Conduct after-action reviews with GRADS Compliance Operations and PV/REMS to learn and improve after any compliance incident.
• Collaborate with GRADS Compliance Process and Training to design strategies to pre-empt compliance issues.
• Partner with GRADS Compliance Operations and GRADS Alliance Management to review vendor metrics for compliance concerns and opportunities.
• Participate in Vendor Governance meetings led by GRADS Alliance Management and provide the compliance lens in assessing presented data.
• Engage in GRADS Alliance Management due diligence teams as requested and contribute to cross-functional compliance initiatives with partners.
• Resolve global compliance or quality issues from partnerships in collaboration with key stakeholders.
• Support compliance analysis in complex situations and provide recommendations to management and senior leaders for CAPAs, commitments, and inspections.
• Assist PV and REMS in developing business continuity plans and lead guidance for future testing and execution of BCP as needed.
• As a member of the GRADS Compliance Leadership team, ensure PV and REMS services are compliant and enabling to the business, acting as a partner of choice.
• Apply business and management expertise to drive operational performance; present complex processes clearly and persuade stakeholders when needed.
• Champion data and scientific integrity, effective use of systems, and proactive quality and compliance initiatives.
• Foster compliance leadership across procedures with global PV and REMS leaders, emphasizing regulatory reference where required.
• Engage Quality teams and support GRADS Compliance partner-aligned risk management strategies, plans, and processes.
• Support Compliance Operations in inspection efforts and in developing responses to regulator questions as required.
• Maintain current knowledge of industry compliance and quality trends in PV and REMS and transfer knowledge to GRADS Compliance.
• Contribute to solutions beyond current responsibilities and manage day-to-day operational issues as needed.

Qualifications

• 8 years of R&D quality or compliance experience or relevant experience in global PV or REMS.
• 5+ years’ experience communicating with senior leaders with proven accountability; excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities.
• Ability to function autonomously at a senior level in a matrix model and in a team environment.
• Travel required: up to 30%.
• Ability to communicate complex information to diverse audiences in verbal and written formats.
• Experience working with multiple departments (R&D, quality, manufacturing, commercial) and across geographies; strong collaboration and drive for innovative, high-quality solutions.
• Proven ability to manage multiple complex activities simultaneously; strategic and critical thinking with independent problem-solving.
• High motivation and alignment with Jazz leadership values.
• Excellent interpersonal skills in difficult situations; sensitivity to cultural differences and experience in multi-country environments.
• Proficient in Microsoft Office, email, and online meeting tools.

Education and Licenses

• B.S. in Science (or equivalent) required; advanced degree preferred.

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. Base pay range for this role is $151,200.00 - $226,800.00, depending on qualifications and experience. Total compensation may include discretionary bonus or incentive compensation and equity grants in accordance with Jazz policies. Benefits include medical, dental, vision, 401k, and paid time off. For more information on benefits, visit https://careers.jazzpharma.com/benefits.html.