US-NJ, Quality Management Systems Governance & Integration Compliance Manager 229287BR-MZ
Quality Management Systems Governance & Integration Compliance Manager
Global Drug Development
East Hanover, NJ
Evaluate procedural documents change requests across GDD. Assess the impact of the change on the document landscape in consultation with the relevant Quality system owner, the process owner / sponsor , lead Subject Matter Expert (SME) and relevant SMEs.
Act as a subject matter expert from GDQ QMS to advise on process documents standards throughout the document lifecycle management process.
Manage and coordinate the final draft document quality check through the document system manager up to release for approval and training.
Fully support a robust quality management system to meet all applicable regulatory requirements and ensuring full inspection readiness at all times.
1. Responsible for Document Lifecycle Management and Control for global development line function covering one or more GxP area.
2. Collaborate with the Process & Training Governance Board (PTGB) line function representative to advise on procedural documents change request, risk and impact assessment, plans and priority.
3. Use risk assessment and risk management tools to support line functions in change request evaluation and implementation strategy.
4. Evaluate change requests in consultation with impacted Quality systems owners, sponsor and /or process owners, PTGB line function representative and Lead SME and advise on GxP relevant risks and required mitigation plan. .
5. Support Lead SME/ authors and SMEs in the definition of procedural documents change strategy.
6. Agree implementation strategy, timelines and followup on progress.
7. Provide inputs to QMS G&I Operations manager to maintain the project management tool as well as the capacity management tool ensuring oversight of all changes endorsed by PTGB.
8. Check Compliance to document standards throughout the document lifecycle management steps
9. Escalate to Process Training Governance Board (PTGB) issues, changes in scope and conflicts impacting the change implementation plan.
10. Acts as Subject Matter Expert representing QMS compliance during the development or update of procedures.
11. Ensure Change request scope is implemented to have relevant Regulations, Quality Manual requirements and outstanding Correctives and Preventives actions appropriately covered in the updated an/or new process documents.
12. Perform the final document quality compliance check.
13. Prepare and send the final document for endorsement
14. Upload the document in the document management system, setup the relevant applicabilities and Initiate the approval cycle.
15. Provide support and guidance to ESOPS document authors, to create/update appropriate, related documents in ESOPS according to DevQA requirements
16. Act as a compliance SME to support process operational excellence and continuous improvement initiatives.
17. Lead process improvement initiatives within development QMS.
18. Support the Quality Manual gap assessment implementation.
19. Support HA inspections and audits requests.
Position can also be filled in East Hanover, New Jersey or Basel, Switzerland.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Degree in science, or related experience
Fluency in English (oral and written)
5 years experience in drug development, of which 3 years within Novartis is a plus
Good understanding of the interdependencies between the different development processes.
Experience in quality compliance and applicable regulations in pharmaceutical industry
Very good interpersonal, problem solving, results driven, communication and project management skills Experience in business process management tools and techniques
Experience in risk assessment and risk management tools.
Quickly acclimates to complex work-flows/processes and organizational complexities. Embraces change and serves as a change leader in fast paced dynamic environment.
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