GCP Inspection Project Manager

Job Description Summary

Provide quality assurance and compliance oversight to development and research functions. Drive the oversight of quality management systems and initiatives within the global, regional, and country organization, ensuring compliance with applicable health authority regulatory requirements (e.g., Good clinical Practice (GCP), Good Laboratory Practice (GLP,) Good Manufacturing Practice (GMP), Pharmacovigilence (PV), Intellectual Property (IP)) and Novartis procedures and quality standards. Role model good quality behaviors while promoting a culture of quality (e.g., right first time, etc.) to positively impact the non-quality stakeholders (e.g., Biomedical Research (BR), Global Development. Develop, drive and/or support Quality plan initiatives in order to achieve organizational strategy, mission and vision.

Job Description

Major accountabilities:

• Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP-relevant process.
• Lead and manage a QA organization and/or quality project team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met -Translate functional QA strategy into applicable operational/compliance activities and support a risk-based implementation and execution of processes.
• Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc. -Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management and follow-up.
• Support quality oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow-up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings
• Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation.
• Contribute towards lessons learned based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics and support a culture of proactive, risk-based behavior
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Quality and timelines of strategic project documentation and presentations: Documentation available on time and of high quality
• Reliable, timely and accurate information/communication about project specific issues and to key stake holders.
• Deliver on departments cost/budget -Establish succession plan
• Role Model of Novartis culture, values, & behaviors

Minimum Requirements:
Work Experience:

• Bachelor's degree in life science or healthcare field required.  Advanced degree or equivalent education/degree in life sciences/healthcare

• 7 years of involvement in regulated activities (GCP/ Pharmacovigilance (PV)), clinical development and/or QA positions.

• Broad understanding of global expectations of Health Authorities in the area of Clinical Development and profound understanding of the science of product

• Extensive Project Management experience

• Ability to work independently and in a global/matrix environment.

• Strong skills in GCP, quality

Languages :

• English.

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:

You'll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

Skills Desired

Agility, Auditing, Audit Management, Business Partnering, Continued Learning, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, ISO 9001, Leadership, Organizational Savvy, People Management, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Stakeholder Management, Technological Expertise, Vendor Management

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