Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

RESPONSIBILITIES

The successful candidate will be responsible to:

• Lead GVP and Regulatory Process related Improvement
• Member of the GRADS leadership team
• Drive, develop, simplify, and finalize processes which drive continuous quality improvement and enhances operational excellence across the organization
• Respond to and collaborate with colleagues on CAPAs that require changes to Labeling, Safety and/or Regulatory Related Operations process modifications
• Oversee GPV and Regulatory Inspection Management
• Drive, establish PV/ Safety and Regulatory quality standards and work processes
• Interact and negotiate process improvements/solutions with process owners, subject matter stakeholders, and functional area teams
• Partner closely with Quality, and all functional areas of GRADS
• Keep abreast of changes in industry/regulatory environment and regulations that would necessitate future changes to Safety and Regulatory Operations-related processes
• Proactively discuss and implement process changes so the company is prepared to respond appropriately to the changes
• Represent function at professional compliance meetings and may present company initiatives at such events
• Lead efforts to increase the commitment to quality in individuals and a culture of quality within the organization
• May represent Safety and Regulatory Operations at worldwide regulatory inspections
• Lead issue and deviation management processes to increase compliance posture
• Lead risk assessment processes to proactively mitigate risks (excluding GCP/GMP/CMC matters)

• Bachelor’s degree
• Advanced degree, such as Master’s or PhD, required
• Expertise and prior leadership roles involving GCP, GVP, and Quality; Audit and Inspection Readiness required
• 15 + years of pharmaceutical or biotech Industry experience, with at least 10 years of direct, relevant PV, Quality or Regulatory compliance experience, is required
• Must have deep knowledge of Labeling, Risk Management, Safety and PV – related regulatory requirements
• Keen understanding of Quality Management Systems
• Understands current global and regional trends in regulatory compliance and ability to assess the impact of these requirements to the business
• Must be able to solve complex problems and use highly developed independent judgment relating to national and international regulations, guidelines, investigator interactions and timelines
• Must think critically, proactively, and creatively and be able to work independently to determine appropriate resources for resolution of complex problems
• Understands impact of decisions and actions on business and consults with appropriate colleagues and management
• Strong leader, and team player who demonstrates initiative, willingness to roll-up his/her sleeves, and problem solve
• Ability to thrive in a fast-paced environment
• Strong writing and communication skills
• Ability to communicate effectively and represent the GRADS organization internally and externally