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
Jazz Pharmaceuticals is an Equal Opportunity Employer.