AD, GXP Learning and Development Lead (12 month FTC)

at  Jazz Pharmaceuticals

IF YOU ARE A CURRENT JAZZ EMPLOYEE PLEASE APPLY VIA THE INTERNAL CAREER SITE.

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.jazzpharma.com and follow @JazzPharma on Twitter.

BRIEF DESCRIPTION:

This position is a global role, part of the Quality Systems group within the global Quality organisation. This position leads a team in the Quality Systems group to ensure that the Global GxP Training & Learning Program continues to meet the requirements of Jazz & is continued to be developed to ensure fit for purpose & compliant operations of Jazz. This includes management & oversight specifically of:

• The Corporate Learning Management System (LMS) – Jazz Learn.
• The global GxP Learning program.
• Development, deployment & improvement of learning standards as applies to GxP’s.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Substantial relevant experience in the pharmaceutical, biotechnology, cGMP or highly regulated industry
• Substantial relevant experience in Senior leadership roles associated with training systems, training deployment/development or adult business learning environments including setting of strategy and delivery against strategy.
• Accomplished people leader with an ability to influence across a matrixed and remote organization.
• Strong knowledge of modern digital Learning Management Systems and solutions
• Thorough knowledge of relevant GxP regulations and guidance as applies to training in the pharmaceutical industry.
• Strong written and verbal communication skills, and analytical problem solving and conflict resolutions skills.
• Flexible, highly motivated, with strong organization skills and the ability to multi-task. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Ability to work independently, drive for results and to make decisions based on experience.
• Interpersonal skills and professional skills to interact & build productive relationships at all levels including senior executives, contractors, and colleagues.
• Experience interfacing with regulatory bodies or supporting regulatory submissions.

REQUIRED/PREFERRED EDUCATION AND LICENSES

• Professional qualification in L&D with excellent knowledge of instructional design, adult learning principles and LMS management
• Qualified to a degree level in a Science or Business discipline.
  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.
  The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html

ESSENTIAL FUNCTIONS

Responsible for developing, enhancing and maintaining the Jazz GxP Learning Management Processes, including the digital LMS (Jazz Learn), to ensure that all operations are fully in compliance with current international standards for GxP & that the Jazz LMS continues to meet the requirement of the business. Specific responsibilities are:

• Lead a team of Learning & Quality professionals in providing a fit for purpose service to the organisation with a continuous improvement and Quality As A Service mind-set.
• Act as Executive Business Owner, ensure the Jazz global digital LMS (Jazz Learn) is fit for purpose, compliant with regulations and continues to evolve to meet the needs of the business.
• Lead the operational business relationship with LMS Vendor and/or Level 2 Support Vendor to build collaborative relationships and ensure ongoing value add support for the Jazz LMS.
• Accountable for the Jazz Learn functional business processes including Jazz Learn Release & Continuous Improvement cycles.
• Ensure Business Admin support capabilities for LMS is suitably resourced and ways of

working defined and executed, including collaboration with IS BPS team.

• Manage and continuously improve companywide systems & business processes for the management of GxP training.
• Engage, coordinate and manage the network wide Training Coordinator matrix group to assure ongoing capability to utilise the LMS and to assure local compliance, business use & oversight for the LMS.
• Assure appropriate training needs assessments are completed, either directly or through engagement of the Training Coordinator matrix.
• Define & implement GxP training standards to assure training interventions are fit for purpose, appropriately build capability, meet business needs and add value.
• Determine effective training approaches to meeting the needs of the business including application of advanced instructional design principles and adult learning models to enhance deliver of content. Deploy these approaches with the business as part of deliver of standards or direct project engagement.
• Design, develop & implement GxP Orientation training for new employees globally.
• Design, develop & implement annual GMP/GDP refresher training programs.
• Own, develop and implement the Global GxP Learning Program to ensure training is in accordance with regulatory requirements, meets business needs, is fit for purpose and ensure that training is delivered at an organisational level and drives improved capability.
• Collaborate with Corporate (HR) Learning & Development to align GxP training approaches with Corporate L&D programs and approaches.
• Collaborate with the QMS team to ensure the Vault SuperUser community is utilised & supported to best advantage of the business & maintains knowledge of the system as it evolves.
• Design, develop and implement metrics to assess the compliance & service level provision of the L&D team; to identify areas of improvement, drive continuous improvement and to assure the system and team continue to meet expectations and service level commitments.
• Support the framework of global, functional & site Quality Management Reviews by provision of data and insights with regard to Learning metrics.
• Facilitate and support inspections by regulatory authorities and maintain a state of inspection readiness. Participate in the development of responses to agency observations or deficiencies and ensure CAPAs are completed in a timely manner with appropriate effectiveness verification.

OTHER RESPONSIBILITIES:

• Work directly with other key Jazz Pharmaceutical departments to ensure compliance and productive working relationships.
• Support Regulatory audits to ensure positive outcomes.
• Work closely with global stakeholders within Jazz to ensure delivery of key project objectives and timelines.
• Ensure cross-functional meetings & stakeholder engagement opportunities are conducted to ensure that the team can collaborate with all stakeholders of the LMS to drive improvements.
• Operate in accordance with the Jazz corporate values.
• Responsible for maintaining relevant Good Practices (GxP) and Health and Safety
  (H&S) knowledge applicable to the job.

This position is a global role, part of the Quality Systems group within the global Quality organisation. This position leads a team in the Quality Systems group to ensure that the Global GxP Training & Learning Program continues to meet the requirements of Jazz & is continued to be developed to ensure fit for purpose & compliant operations of Jazz. This includes management & oversight specifically of:

• The Corporate Learning Management System (LMS) – Jazz Learn.
• The global GxP Learning program.
• Development, deployment & improvement of learning standards as applies to GxP’s