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 Trial Management, Monitoring, Regulatory Writing and Global Submission and as required provides ancillary support for External Operations Development Services (EDO) quality oversight/management. The position contributes to the implementation of a risk-based quality management process in Global Development Operations (GDO) and responsible as the Quality representative in providing quality governance and oversight to Global Development Operations (GDO) assigned activities.
1.Collaborates with Global Development Operations (GDO), other Global Development Quality (GDQ) groups, and Country QA to ensure International Council Harmonization (ICH)/GCP requirements are fully met via the implementation of a risk-based implementation and execution of the Global Development Operations (GDO) processes.
2.Collaborates with Global Development Operations (GDO) and other Global Development Quality (GDQ) (e.g. Compliance and Clinical Quality Assurance (CQA)), groups to identify and participate in continuous improvement initiatives and work streams and to address process improvements and ensure identified gaps are properly addressed and executed for sustainability including:
Effective implementation of the new monitoring process (e.g. [click here] operational implementation, Risk-based monitoring (RBM), etc.)
May Lead or Co-Lead Quality and compliance initiatives as required and assigned to (Global Drug Development (GDD), STRIDE, TMF Governance, Risk Based Monitoring (RBM) teams, etc.).
The design and implementation of respective quality/compliance activities and changes that incorporate quality risk assessment.
The implementation of strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc. to meet Novartis requirements and identify opportunities for continuous improvements
3.Contribute to and monitor the implementation of the annual Quality Plan pertaining to Global Development Operations (GDO) deliverables and ensure that delayed activities have a rational and appropriate escalation
4.Supports and leads process improvement, risk management and specific QA projects, in collaboration with Global Development Operations (GDO) and other Global Development Quality groups.
5.Support inspection readiness activities in collaboration with Global Development Operations (GDO), other Global Development Quality groups, Country QA, and Group Compliance and Quality (GCO) by maintaining a continuous state of inspection readiness within Global Development Operations (GDO) through active participation in regulatory inspection preparation, management and follow-up.
6.Provide quality oversight by:
Timely escalation of deviation/incidents to ensure adequate and timely escalation of issues to Global Drug Development (GDD), Global Development Operations (GDO), and Global Development Quality (GDQ).
Providing functional Quality oversight for deviations/incidents ensuring robust investigations, root cause analysis and corrective actions are defined, implemented and closed.
Liaise with Global Development Quality (GDQ), Group Quality and Corporate Audit groups for audit planning activities
Provide support to Global Development Operations (GDO) for development of Corrective and Preventative Action (CAPA) plans for audits, inspection and quality events. Follow-ups on CAPA completion as assigned Follow-up Responsible Person (FURP).
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 toward materials used of Quality Review session and lessons learned for Global Development Operations (GDO) based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics.
7.Drive a culture of proactive, risk based behavior focused on identifying opportunities for use of innovative processes and technologies where applicable.
8.Deputy for Global Head in their absence
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
1.At least 10 years of experience in clinical development and the pharmaceutical industry, including work as a monitor (CRA) and Clinical Development. Preferably 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) guidance s, and current industry practice.
3.Knowledge and application of Quality Risk management principles.
4.Excellent verbal and written communication skills.
5.Excellent negotiation and conflict resolution skills
6.Resolves issues with minimal supervision and understand when to escalate.
7.Excellent problem solving and decision-making skills. Skilled at conflict resolution / negotiation.
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