Executive / senior industry position
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 opportunity is available in Dublin, Ireland or Palo Alto, US.
Reporting to the Associate Director QA-IT in the Quality Services group within Technical Operations. The Quality Services group oversee contract manufacturing operations, supply chain operations, development, internal Quality Systems with the QA-IT team foussing on the validation of Compuertized Systems (across all GxPs).
The Senior Manager QA-IT provides quality oversight for complex GxP systems in an accurate, timely, consistent, and quality driven manner and supports a range of cross-company initiatives where CSV and Data Integrity expertise is required.
Works with Project Managers, System Owners and Business Process Owners to ensure timelines for system implementations milestones are met
Informs project management and senior leadership of overall quality oversight and review status and communicates potential problems in a timely manner
Support the full validation lifecycle for GxP systems including, but not limited to; the review and approval of Validation/Qualification Plans, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ, PQ), Data Migration deliverables, Periodic Reviews, Change Controls, Deviations and Retirement deliverables
Advise on complex risk scenarios directly affecting our GxP systems via interactive meetings, workshops and cross functional meetings with Jazz colleagues and be able to reference appropriate regulations and guidance as required
Participates in the development and maintenance of SOPs and working practices related to quality, GxP, CSV and Data Integrity and evaluates new technologies and delivery / oversight approaches
Executes a range of Internal and External audits, in particular software providers
Supports sites, functions and CMOs/CLOs where CSV and Data Integrity expertise is required (e.g. review of current procedures/practices and gap analysis, inspection support/response, QTA review)
Contributes to the development of Data Integrity awareness training and guidance
Trains, mentors and coaches individuals within QA-IT and wider functions in aspects of CSV and Data Integrity
Drives operational excellence initiatives and leads company wide data quality improvements
Required Knowledge, Skills, and Abilities
Subject matter expertise for assuring that validation deliverables for GxP computerized systems meet the requirements of US, EU and other international regulatory agencies
Familiarity with a wide range of delivery (e.g. waterfall, agile) and hosting (in-house, IAAS/PAAS/SAAS) models
In-depth knowledge of 21 CFR Part 11, Annex 11 and curent regulatory guidance on Data Integrity
Understanding of FDA, GxP, and ICH regulations related to GMP and GDP and experience with computerized systems used in manufacturing and laboratory (e.g. Chromatography, LIMS)
Awareness of GLP, GCP, GVP regulations/systems and other regulations (e.g. GDPR) an advantage
Data Integrity oversight experience at CMO, CRO and CLO facilities
Qualified auditor with the ability to conduct internal and external audits
Established interpersonal skills and respectful collaborative approach with internal and external stakeholders
Excellent verbal and written communication skills
Ability to measure/monitor (informally and via KPIs/Metrics) and subsequcntly drive continuous improvement initiatives
Highly developed risk assessment and critical thinking capabilities
Required/Preferred Education and Licenses
Degree in Chemistry, Biology or Computer Science with previous validation oversight experience
10 years experience in pharmaceuticals or a related field
Qualified QMS, GxP, CSV or IT auditor
Description of Physical Demands
Travel for audits and occasional 'non standard' working hours (e.g. System Go-Live) in order to meet business demands