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.
This position is a global role, part of the Quality Systems group within Technical Operations organisation based in Dublin. This position leads a team in Quality Systems to meet the global requirements of Jazz for Product Quality Complaints, Documentation Control, Change Control, Deviations and CAPA's. This role is also responsible for Management Review, Quality Councils, oversight of the MAH process and reporting of quality metrics.
Our therapeutic areas of focus include sleep and haematology/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.
Responsible for developing, enhancing and maintaining Quality Systems activities to ensure that all operations are fully in compliance with current international standards for GxP. Additional responsibilities are:
- Lead and direct GxP processes for CAPA, complaints, change management, deviation management and document & archival management. Manage the Pharmaceutical Quality System (PQS) process and compliance team as per ICH Q10, including Product Quality Complaints, Change Control, Deviation and CAPAs
- Manage the Management Review process including CAPA, deviations, document management and change control, ensure appropriate escalation of adverse trends. This includes the monthly Quality Council and 6-monthly Management Review meetings
- Design and implement quality metrics to assess the compliance of the PQS; to identify areas of improvement and support associated initiatives. This includes oversight of the interactive dashboard and the balanced scorecard
- Assure that deviations to procedures are captured and an impact assessment is conducted as appropriate
- Ensure a robust CAPA program is in place with robust and timely processes for root cause analysis, verification of actions and effectiveness checks
- Lead the process for reporting, investigating and trending product complaints. Ensure procedures are established to identify if a product complaint is reportable under applicable worldwide regulations and document the decision process
- Drive the GMP change management program and implement efficient processes for the notification, assessment and implementation of changes to support program timelines
- 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 timely with appropriate effectiveness verification
- Ensure Quality and Technical Agreements are strategically aligned with QMS requirements for notifications and delegation of responsibilities
- Develop the QMS team with identification and on-boarding of key positions in oversight of quality management systems and applicable regulations
- Drive operational excellence and continuous improvement within the team including Operational Excellence huddles to ensure the Quality System meets Jazz Pharmaceuticals growth requirements through innovative solutions
- Ensure Technical and Compliance QS training is rolled out to users as required, assess the effectiveness of this training and update as required
- Oversight of the training coordination process for the wider Quality Systems team
- Lead and ensure effectiveness of the Quality Risk Management process
- Manage the MAH data collection and co-ordination process, ensure quarterly reports are prepared and circulated. Ensure the process is assessed for effectiveness and is continually improved. Ensure new MAH's are included in the process
- Act as BPO for the eQMS system, Reliance, includes attending CAB meetings and management of changes and enhancements to ensure the system continues to meet the needs of the business and users
- Work directly with other key Jazz Pharmaceutical departments to ensure compliance and productive working relationships.
- Work closely with global stakeholders within Jazz to ensure delivery of key project objectives and timelines
- Perform internal and external audits as appropriate in either a lead auditor role or as part of a team
- Supporting regulatory submissions to ensure impacted licenses are maintained in compliance
- Ensure cross-functional QS meetings are held so that QS can collaborate with all stakeholders of the eQMS to drive improvements
Education: Relevant Scientific or Pharmacy degree required; advanced degree preferred. EU Qualified Person eligibility an advantage.
- Strong expertise in quality metrics reporting, analysis and process improvement techniques
- Thorough knowledge of relevant GxP regulations and guidance to include but not limited to 21 CFR 2010 and 211, ICH Q8 Q9 Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, HPRA, MHRA
- 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 and to make decisions based on experience
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues
- Experience working in finished product pharmaceutical/ biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
- Experience interfacing with regulatory bodies or supporting regulatory submissions
Jazz Pharmaceuticals is an Equal Opportunity Employer.