Manager Quality Mgmt Systems Governance & Integration Lifecycle Mgmt
Global Drug Development
East Hanover, NJ
Lead the implementation of operations excellence and standards across GDD, including tracking progress to measure Key Quality Indicators (KQIs), QMS relevant Quality Plan actions and overall compliance to applicable processes and regulations across Global Quality Management systems (QMS).
Support initiatives within QMS to support process improvement and quality performance to proactively identify and address areas of concerns to avoid downstream issues.
Fully support a robust quality management system to meet all applicable regulatory requirements, and ensuring full inspection readiness at all times.
Manage in a matrix team the Global Network of ESOPs managers across GDD (share learning, set standards, system owner, training (system users, SMEs, authors), improvement initiatives)
1. Act as Subject Matter Expert (SME) in process improvement initiatives and oper-ational excellence in support of a robust Quality Management System for Devel-opment.
2. Maintain Document Lifecycle Management process and standards (QC Checklist, document Review and Approver list, SME database, Resources and systems list, documents update tracker).
3. Triage of all process change request submitted in GDD and assigns the process changes to compliance managers.
4. Maintain the change request tool
5. Monitor the QMS implementation of document change requests endorsed by PTGB
6. Bi-Annual Quality check (QC) audits of document lifecycle management process
7. Manage the capacity demand tool within QMS G&I
8. Share learning, set standards, act as system owner for document lifecycle man-agement system
9. Develop training (system users, SMEs, lead SMEs/ process document authors),
10. Responsible for handling deviations in QMS G&I including follow-up on open actions till closure.
11. Support inspection readiness and accountable for overall management of legacy procedures.
12. Serve as a member of the Pharma-level ESOPS Business User Committee (BUC), responsible for identifying/analyzing process related business questions/issues, and corresponding follow-up.
13. Lead the cross-functional SOP Managers Group across Global Drug Development to ensure standards are understood, supported and consistently applied and followed throughout the organization. Takes appropriate action and escalates in case of non-adherence.
14. Champion overall approach for onboarding training of end users in various QMS systems; assesses training needs, curriculum plans and global training materials as needed. Performs training as required to the GDD organization.
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.
Life Science/biomedical, pharmacy degree, or scientific degree.
Fluency (oral and written) in English, any additional language is a plus
Minimum of 8 years of relevant experience in pharmaceutical development and working in a GxP regulated area (preferably including GCP), with broad understanding of global expectations of Health Authorities in the area of Pharma Development Pharmaceutical development Organizational awareness (e.g. inter-relationships of departments, business priorities), including experience working cross-functionally and in global teams.
In depth knowledge and working experience with common computer software programs, and document management systems and controls i.e. MS Office Suite (Word, Excel, Outlook, Sharepoint, PowerPoint, Visio, MS Project)
Effective training and facilitation skills.
Demonstrated leadership in implementing robust quality systems and setting global quality controls in a regulated area.
Excellent leadership, interpersonal, communication, negotiation and problem solving skills Proven self-starter with experience in initiating and ensuring delivery of geographically and functionally diverse teams
Self-motivated with a high degree of ownership and accountability for results.
Quickly acclimates to complex workflows/processes and organizational complexities. Embraces change and serves as a change leader in fast paced dynamic environment.
Proven track record working with multinational teams
Demonstrated ability in handling complex, technical issues and providing timely reporting.
Good written, presentation and verbal communication skills
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