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.
The purpose of this description is to provide a statement of the essential functions and requirements for the position and to organise and present the information in a standardized way. It is not intended to describe all functions, knowledge, skills, abilities, or working conditions that may be required for this position, nor should it serve as the sole criteria for personnel decisions and actions.
The position is responsible for monitoring and supporting the day-to-dayQuality activities relating to the performance of contract manufacturing organisations andmaterial suppliers to all applicable GXP standards. This position also involves membership of the External Manufacturing Product Teams.
Responsible for but not limited to:
• Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product related investigations
• Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations
• Collaboration with all contract manufacturers, packagers and testing laboratories to resolve any quality issues.
• Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, packagers and laboratories, as required.
• Highlighting any risks associated with maintaining supply of commercial drug products to all markets
• Conducting vendor audits and vendor site visits as required
• Assisting in internal audits and regulatory agency inspections
• Processing out-of-specification (OOS) reports and provision to Jazz QC for review
• Reviewing product stability data and provision of data to Jazz QC for review and trending
• Reviewing and summarising CMO Annual Product Quality Reviews and supporting regulatory submissions
• Maintaining product related Quality Technical Agreements (QTAs)
• Understanding new regulations and guidelines, as they apply to the company business and implement systems and procedures to incorporate these new regulations as appropriate
• Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest.
• Communicate, where appropriate, with all corporate personnel and contribute to the development of global systems and procedures, as required.
• Contribute to the design and implementation of best practice quality improvement programmes and company expansion programmes.
• Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
• Contribute, as required, to the development of new drugs, which will deliver a robust product pipeline without significant delays in the regulatory approval process.
• Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
• Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
• Bachelor’s degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology or a related discipline
• Significant experience (5-10 years) working in finished product pharmaceutical / biologics, including validation, analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
• Eligibility to act as a licensed Qualified Person across a number of dosage forms is extremely desirable
• Thorough understanding of Quality Systems and cGMP’s.
• Experience with third party vendor auditing, out of spec investigations, change control
• Experience working with contract manufacturing
• Experience interfacing with regulatory bodies or working on regulatory submissions
• Highly organised, with exceptional time management and prioritisation
• Critical thinking and evaluation of process problems
• Excellent verbal and written communication skills
• Patient and results focused
• Good Leader and highly motivated.
• Collaborative team player
• Strong work ethic with a flexible and adaptable approach
Jazz Pharmaceuticals is an Equal Opportunity Employer.