Senior Associate, GRADS Compliance Operations, Regulatory and Labeling (Remote)

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

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to

transform the lives of patients and their families. We are dedicated to developing

life-changing medicines for people with serious diseases — often with limited or no

therapeutic options. We have a diverse portfolio of marketed medicines, including leading

therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

Our patient-focused and science-driven approach powers pioneering research and development

advancements across our robust pipeline of innovative therapeutics in oncology and

neuroscience. Jazz is headquartered in Dublin, Ireland with research and development

laboratories, manufacturing facilities and employees in multiple countries committed to

serving patients worldwide. Please visit

www.jazzpharmaceuticals.com

for more information.

Brief Description :

Under the leadership of the GRADS Compliance Operations, this role is responsible for the execution of issue management processes, assisting and / or leading audit and inspection processes and preparing for governance meetings to achieve compliance, inspection readiness, and continuous improvement across the Regulatory and Labeling organizations.

Essential Functions / Responsibilities

• Responsible for all aspects of day-to-day issue management, communication, and escalation, CAPA resolution, documentation and timely communication to stakeholders and health authorities as appropriate.
• Manage and / or Advise on deviations and change control management process.
• Partner with Quality, Regulatory Affairs, Regulatory Operations and CMC and Labeling organizations in inspection readiness forums.
• Assist with all inspection management activities across Regulatory Affairs, Regulatory Operations and CMC and Labeling including developing readiness and execution plans such as training, storyboards, rehearsals, front and backroom support, notifications, logistic coordination, providing direction / coaching, schedules, ensuring appropriate subject matter experts are prepared, preparing for daily debriefs and close out meetings.
• Assist with post inspection activities including after action reviews, coordinating meeting and information, and ensuring timely responses.
• Collaborate with the GRADS Compliance Regulatory and Labeling Partner to ensure continuous improvement efforts are aligned and that the appropriate management reviews are established.
• In partnership with GRADS Compliance Regulatory and Labeling Partner, attend and participate in after-action reviews 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 Alliance Management to review metrics provided by GRADS Regulatory Affairs, Regulatory Operations and CMC and Labeling vendors for compliance concerns and opportunities.
• Participate in Vendor Governance meetings led by GRADS Alliance Management and attended by GRADS Compliance Regulatory and Labeling Partner.
• Partner with internal stakeholders to resolve any Regulatory and Labeling compliance or quality issues resulting from executed partnerships.
• Partner with GRADS Compliance Regulatory and Labeling Partner to lead in the compliance analysis in complex Regulatory Affairs, Regulatory Operations and CMC situations and provides recommendations to management and senior leaders in support of CAPAs, commitments, and inspections.
• Act as an anchor to the commitment to data and scientific integrity, the efficient and effective use of systems, and driving quality & compliance proactively.
• Engage with GRADS Compliance Regulatory and Labeling Partner in inspection efforts and developing responses to regulator questions as required.
• Act as internal investigator for the GRADS Compliance, reporting any discovered disparities and discrepancies to the Head of GRADS Compliance        or delegate.
• 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 : $105,600.00 - $158,400.00

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 : https : / / careers.jazzpharma.com / benefits.html .