New York, NY
Washington, District of Columbia, United States
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.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
To provide QA compliance oversight during the implementation and maintenance of computerized system lifecycle within R&D, Corporate and Manufacturing functions. Furthermore, will be responsible of auditing internal process, systems, and vendors to ensure compliance and adherence to company standards and regulatory requirements.
- Provides independent quality review and approval of validation deliverables. Completes independent quality review of validation deliverables associated with assigned systems to ensure that the company policies and procedures are being adhered to.
- Verifies that data integrity principles are adhered to within the company.
- Completes pre and post-test execution review of test scripts to ensure that all scenarios have been appropriately identified and test coverage is adequate
- Provide expert advice to business owners, system owners, Information Services – Compliance team and wider business operations
- Conduct and/or support internal audits, vendor audits and regulatory inspections as a subject matter expert
- Reviewing and approving change controls for applications and infrastructure
- Prepares for and supports Sponsor inspections/external audits conducted by national and international regulatory authorities and other external bodies such as marketing partners.
- Promotes quality by design awareness amongst company personnel and develop and maintain company GCP, cGLP, GLP, GMP, GPvP and other quality standards by means of training, review, advice, and guidance services
- Promotes a culture of quality excellence that encourages ethical conduct and a commitment to compliance, resulting in a positive image to both company and external personnel.
- Supports the Company’s risk-based Quality Management System (QMS) from design, implementation and execution through life cycle management resulting in a culture of continual processes improvement.
Required Knowledge, Skills, and Abilities
- Typically, Bachelor’s degree in science or related discipline. Post-graduate qualifications (Master’s, PhD) preferred
Experience and knowledge:
- Typically, 8+ years relevant work experience in the Pharmaceutical, Biotechnology or a related industry within Quality Assurance Department
- Minimum of 5 years’ experience overseeing validation and implementation of computerised systems within a regulated framework
- Minimum of 3 years’ experience working within a life-sciences auditing function
- Detailed knowledge of Computer System Validation Methodologies
- Direct experience in implementing systems using Agile
- Solid Knowledge of GCP, GLP, GMP and/or GVP regulatory requirements
- In depth understanding of 21 CFR Part 11, EU Annex 11 GMP, and MHRA GxP Data Integrity Guidance.
- Experience implementing SaaS Systems
- Sound understanding of risk-based system validation
- Working knowledge of office IT packages
- High level of written and verbal communication skills
- Good organisational skills and the ability to work independently or as part of team
- Excellent attention to detail and the ability to identify the root cause of problems
- Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and work effectively in a multi-disciplinary team
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.