Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
Jazz Product Quality and Occupational Toxicology (PQOT) is responsible for providing robust, scientifically-sound hazard and risk assessments to support product quality activities, primarily associated with manufacturing, and health and safety of the workplace for employees handling proprietary and non-proprietary chemicals used in the production of Jazz products.
The Senior Director is primarily accountable for product quality/occupational toxicology, working in collaboration with nonclinical toxicology, TechOps, Global Quality to drive the overall global regulatory strategy and coordination of product quality/occupational toxicology for multiple Jazz portfolio products, from research to registration and beyond. The individual has experience in evaluating and responding to product quality/occupational toxicology inquiries from global regulatory authorities in support of major submissions and commercial batch release. The individual represents the department at the project team level while directing outsourced activities in collaboration with study monitors and project managers, to enable timely high-quality project deliverables.
tactical and strategic leadership in compliance with corporate policies and standards and global regulatory requirements
advising project teams on product quality-related concerns (e.g., specifications for known impurities, evaluation of leachables/extractables,
assessment of potential genotoxic impurities;
authoring human health risk assessments required for small and large molecule manufacturing (e.g., determination of permissible/acceptable daily exposure (ADE/PDE),
occupational exposure limit (OEL), and
maximum allowable carryover (MAC) values);
co-authoring material safety data sheets for Jazz commercial products in collaboration with CMC;
oversight of environmental risk assessments that NDA/BLA; and
addressing other relevant issues on an ad hoc basis.
Responsible for review of scientific and strategic aspects of risk assessments prepared by others prior to finalization and regulatory submission.
Responsible for upholding Jazz Standards related to Product Quality/Occupational toxicology in compliance with US and ex-US guidelines
Developing standard operating procedures, departmental processes and templates, as-needed
Required Knowledge, Skills, and Abilities
This is a highly interactive position within a cross-functional matrixed environment. This position requires a solid proficiency in a broad variety of scientific (e.g. toxicological) and technical skills to perform hazard/risk assessment, hazard communication, and other toxicology-based assessments in accordance with compliance to departmental, corporate, and regulatory requirements.
Required/Preferred Education and Licenses
Description of Physical Demands
Description of Work Environment
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.