US-NJ, Associate Director Clinical Operations QA 213614BR-MZ
Associate Director Clinical Operations QA
Global Drug Development
East Hanover, NJ
The Associate Director Clinical Operations QA provides key operational Quality Assurance (QA) support for Global Development Operations (GDO) including all Good Clinical Practice (GCP) relevant sub-functions such as Clinical Trial Management and Monitoring and External Operations Development Services (EDO) quality oversight/ management. The position is the quality representative for the implementation of a risk-based quality management process in GDO and other GCP relevant processes and priorities in GDO.
1. Collaborate with Business partners, other Global Development Quality (GDQ) groups and Country QA to ensure International Council Harmonization (ICH)/GCP requirements are fully met
2. Ensure identified quality and compliance gaps are addressed including but not limited to:
Effective implementation of the new monitoring process (e.g. [click here], Risk-based monitoring, etc.)
Lead or Co-Lead Quality and compliance initiatives as required and assigned to GDD, (STRIDE, TMF Governance, RBM teams, etc.)
Clinical Development Quality Operations participation in respective EDO External Relationship Management Teams (ERMTs), based on functional QA expertise. Leads or Co-chairs the joint quality council.
The design and implementation of quality/compliance activities and strategic process improvement
3. Contribute to and monitor the implementation of the Quality Plan pertaining to GDO deliverables and ensure delayed activities have a rational and appropriate escalation
4. Support inspection readiness activities, other GDD Quality groups, Country QA, and Group Compliance and Quality by maintaining a state of inspection readiness within GDO
5. Supports quality oversight/management of external service providers and their respective functions/ services. Participates in the oversight and governance of External Service Providers (ESPs) in External Relationship Management Teams (ERMTs) /EDO
6. Provide quality oversight by:
Escalation of deviation/incidents to ensure adequate and timely escalation of issues to GDD, GDO, and GDQ.
Providing functional Quality oversight for deviations/incidents ensuring robust investigations, root cause analysis and corrective actions
Liaise with GDQ Audit group for external audit planning and provide adequate support for audits and CAPA follow-ups.
Supporting the business to implement a self-assessment/self-inspection process on defined Global Development Operations (GDO) activities.
Participating in the development of respective training materials and their delivery in internal business functions.
Identify ways to continuously improve quality and compliance with regulations & company policies/procedures through partnership with Global Drug Development (GDD) and Global Development Quality (GDQ) groups
Contributing towards lessons learned for external management based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics.
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 Life Sciences, Pharmacy or Medicine
Fluency in English (oral and written)
1. At least 10 years of experience in clinical development and the pharmaceutical industry preferably with at least 3 years in Quality Assurance/ Compliance roles.
2. Thorough knowledge of international GCP regulations including Food and Drug Administration (FDA)/ European Union (EU) GCP, ICH, pharmacovigilance, new drug regulations, other key Health Authority (HA) guidances, and current industry practice
3. Excellent verbal and written communication skills.
4. Excellent negotiation and conflict resolution skills
5. Resolves issues with minimal supervision and understand when to escalate 6. Excellent problem solving and decision-making skills. Skilled at conflict resolution / negotiation.
7. Excellent multi-disciplinary project management skills
8. Flexibility to react to changing priorities in a dynamic business environment 9. Considerable organization awareness (e.g. inter- relationship of departments, business priorities)
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