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
The Manager, Clinical and Pharmacovigilance Quality Assurance for Pharmacovigilance (PV) system is a significant contributor to Global Quality and is responsible for coordinating activities to regularly verify that Jazz PV system Vendors, commercial partners and Jazz Global R&D/Quality and other teams are operating in line applicable regulations, industry standards, Jazz policies, procedures, and quality standards in support of the Quality Management System & PV system.
In addition, the Manager will support Global Quality/ R&D leaders in providing strategic input and tactical implementation for pharmacovigilance system activities and projects, identify and communicate compliance risks, oversee action plans to mitigate risks (if applicable), and be actively involved in inspections and inspection-readiness activities. This person will participate in interdepartmental teams meetings and at times may be asked to perform activities to support other GxP areas, quality operations, and global quality systems.
Essential Functions
- Gain and maintain professional expertise and knowledge of local and international regulations relative to pharmacovigilance system and quality
- Contribute to the execution of Global PV system audit strategy, and implementation within the Quality Management System
- Perform reviews on internal and external SOPs; participate in the development of SOPs for Quality or PV System stakeholders
- Support updates of the quality related sections in the Pharmacovigilance System Master File (PSMF) or similar documents
- Perform execute and evaluate PV-System auditee risk assessments
- Coordinate and implement strategic audit plans for pharmacovigilance system activities that include service providers, vendors, business partner, and internal audits.
- For pharmacovigilance system audits conducted directly by Jazz personnel or conducted by a vendor on behalf of Jazz (external audits) participate as auditor/co-auditor and/or manage the relationship with the vendor.
- Present QA findings/observations to in-house staff and, if appropriate, to the responsible service provider, vendor, or partner company.
- Contribute to the evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.
- Participate in inspection readiness and inspections as assigned. May perform one or more inspection roles during an inspection (e.g. inspection readiness training, runner, scribe, backroom lead, SME preparation, QA checks, etc.)
- Identify and escalate critical quality issues to senior Quality management
- Contribute to the development of continuous quality process improvements and the identification of identifying root causes for investigations and effectiveness checks if appropriate
- Represent CPVQA within interdepartmental teams / project groups and innovation projects
- Maintain current training in accordance with the training curriculum
- This position may require up to 30% travel
Required Knowledge, Skills, And Abilities
- Established Pharmacovigilance or Quality professional Strong GVP knowledge & expertise
- Excellent written and verbal communications skills
- Ability to work in an entrepreneurial and fast-paced culture.
- GVP auditing experience is preferred.
- GVP lead auditor certification is desirable.
- Self-directed and ability to take action as needed with oversight.
- Ability to collaborate and partner with various internal and external business partners
- Ability to work in a team environment.
- Disciplined, detail orientated, and strong time management skills
- Knowledge of post-authorization commitment requirements is preferred (Phase IV, PASS Studies) and Managed Access Programs (PSPs/MRPs, Early access etc.) is desirable.
- Knowledge and experience with GCP, GLP, and GDP is a plus.
- Inspection experience with FDA, MHRA (or other EU Competent Authorities); experience with emerging markets Regulatory Authority such as PMDA a plus.
Required/Preferred Education And Licenses
- Bachelor’s degree in a related field is required; Master’s degree in management, leadership or scientific discipline a plus.
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.
