Essential Functions Leadership, Visibility & Quality Ownership Lead the GPLO function with a quality‑first mindset, ensuring clear ownership, robust process adherence, and proactive issue identification and escalation. Act as a visible operational leader who role‑models accountability, transparent communication, and cross‑functional partnership. Set the tone for high performance and continuous improvement, driving clarity, consistency, and compliance across all labeling operations. Operational Excellence & End‑to‑End Labeling Quality Oversee the entire labeling workflow to ensure right‑first‑time creation, revision, and management of printed labeling materials. Maintain and continuously improve controlled records, audit trails, and traceability for historical and current labeling changes. Ensure global labeling processes meet regulatory, quality, and internal governance standards at all times. Lead GPLO representation in Quality Management System (QMS) processes, including change control, deviations, CAPAs, and SOP governance. Cross‑Functional Leadership & Strategic Influence Serve as the primary operational interface between GPLO and Quality, GRADS, Technical Operations, Supply Chain. Provide expert interpretation of regulatory and policy requirements, and ensure global alignment on labeling execution. Influence and partner with senior stakeholders to drive strategic improvements in labeling systems, templates, and processes. Inspection Readiness & Risk Management Lead from the front in preparing the organization for audits and inspections, ensuring GPLO processes and documentation are consistently inspection‑ready. Anticipate and manage labeling risks proactively by implementing early visibility mechanisms, dashboards, and quality controls. Support root cause investigations and CAPA development, ensuring sustainable and systemic corrective actions. Process Improvement & Efficiency Identify, design, and implement scalable process improvements that reduce complexity, improve cycle times, and enhance operational predictability. Build and maintain standardized global operating procedures, templates, and best practices. Leverage data and metrics to deliver clear, actionable insights to senior leadership, increasing transparency and accountability. Team Leadership, Development & Culture Build a high‑performing team through coaching, development, and role clarity, ensuring GPLO operates with strong technical skill and leadership maturity. Foster a team culture grounded in quality, transparency, ownership, and continuous learning. Ensure team members have the capabilities, tools, and support they need to execute at a high standard. Required Knowledge, Skills, and Abilities Demonstrated ability to lead from the front with strong operational judgment, strategic thinking, and a proactive approach to problem‑solving. Proven track record of ensuring quality at source, including quality control, documentation excellence, and regulatory compliance. Strong ability to create visibility through metrics, dashboards, and structured reporting. Deep experience in global regulatory labeling, operations, or related regulatory functions. Exceptional collaboration skills, with the ability to influence senior leaders, negotiate priorities, and drive cross‑functional alignment. Excellent communication skills, with the ability to simplify complex concepts and provide clear direction. Demonstrated ability to lead teams through change, ambiguity, and evolving regulatory landscapes. Required/Preferred Education and Licenses Bachelor’s degree (or equivalent experience) required; advanced degree preferred. Progressive pharmaceutical industry experience, including global labeling or regulatory affairs. Demonstrated leadership experience managing teams and leading cross‑functional initiatives. #J-18808-Ljbffr
A leading pharmaceutical company in Dublin seeks a qualified professional to oversee the GPLO function with a focus on quality, operational excellence, and cross-functional leadership. The ideal candidate will lead teams to ensure compliance with regulatory standards, influence strategic improvements in labeling processes, and foster a culture of continuous improvement. This role requires a bachelor's degree, experience in the pharmaceutical industry, strong leadership skills, and the ability to manage complex regulations for successful outcomes. #J-18808-Ljbffr
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. The Director of Drug Product Development is responsible for providing scientific and technical leadership for Jazz Pharmaceuticals’ Pharmaceutical Development programs at various stages of the development life‑cycle including preformulation, formulation and process development, technical transfer and validation. The Director of Drug Product Development will oversee drug product aspects of development and manufacturing projects from pre‑formulation and product feasibility through to clinical trial supply and technology transfer/commercialization. In addition, the Director of Drug Product Development will be expected to provide leadership of cross‑functional CMC development teams. The Director of Drug Product Development will have extensive experience in pharmaceutical product development, demonstrated problem solving ability, module 3 authorship, development of robust manufacturing processes through designed experiments and data analysis, and excellent project management, teamwork and leadership skills. Essential Functions Leads the development of small molecule drug product formulations, appropriate to the phase of pharmaceutical development, with sufficient stability and robustness for clinical and/or commercial manufacturing. Responsible for specifying product and process requirements, including manufacturing equipment and methods, performance criteria, materials, test protocols, required analytical methodology, packaging (clinical and commercial); and in developing robust processes for pharmaceutical production. Directs projects and leads cross‑functional teams with technical proficiency, scientific creativity, collaboration with others to achieve project goals on time and within budget. Create intellectual property covering Jazz Pharmaceuticals products and ensure freedom to operate in the development of new drug products. Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs). Direct technical projects (internally and at CDMOs) including developing detailed technical work plans and managing performance of vendors. Work cooperatively with, or lead, internal and external teams as required. Author CMC sections of regulatory dossiers for products at all stages to enable acceptance by global regulators. Supports asset due diligence and new product introduction and integrations. Apply current knowledge of cGMP and industry standards for process design and validation to manage vendors and contract development organizations. Assist other department team members in providing guidance / mentoring / reviewing documents / data in support of product development (e.g. clinical protocols, PK study results). Enhance and improve ways of working in Drug Product development, utilising knowledge of industry best practice. Required Knowledge, Skills, And Abilities 10 – 15 years’ experience in drug product development in the pharmaceutical industry required. Direct experience with formulation development, process development, technical transfer and/or process validation. Demonstrated technical proficiency, engineering, collaboration with others, and independent thought. Strong track record in delivering achievements with meaningful impact in Pharmaceutical Development projects. Demonstrated ability to lead cross‑functional CMC Development teams. Demonstrated troubleshooting and problem‑solving skills including the use of designed experiments, statistical process control. Development/authorship of CMC regulatory filings for pharmaceutical products. Experience in defending processes, procedures and investigation during Regulatory Agency inspections desirable. Track record in generating intellectual property development. Broad exposure to multiple drug delivery technologies and knowledge of standard dosage forms. Excellent written and verbal communication skills, with demonstrated ability to communicate at executive leader level. Current knowledge of quality systems and FDA and EU regulations as they relate to pharmaceutical development and validation. Proven project management skills for technical programs. Flexibility to travel on company business when required. Required/Preferred Education And Licenses Master’s degree, PhD, or equivalent combination of education and work‑related experience required. Description Of Physical Demands Occasional mobility within office environment. Routinely sitting for extended periods of time. Constantly operating a computer, printer, telephone and other similar office machinery. 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: $198,400.00 - $297,600.00. 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 visit https://careers.jazzpharma.com/benefits.html. #J-18808-Ljbffr
A biopharmaceutical company in Dublin is seeking a Director of Drug Product Development to lead scientific and technical leadership in developing life-changing medicines. The role involves overseeing drug product development from formulation to clinical trial supply, requiring a minimum of 10 years' experience in the pharmaceutical industry. You will work with cross-functional teams on various projects and ensure compliance with regulatory standards. This position offers competitive compensation and benefits in a supportive work environment. #J-18808-Ljbffr
