Job ID
362325BR

Feb 15, 2023

India

100,000+ That\xe2\x80\x99s how many patients participate in our clinical trials at any given time. GCO is Novartis\xe2\x80\x99 powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine \xe2\x80\x93 imagine the impact you could have! #GCO

The GCP Compliance Head (Asia hub) is accountable for the compliance oversight and control of regulated Global Clinical Operations (GCO) activities within scope all GCO managed clinical trials, GCO provided services and a focus on Asia Hub & Country level delivery including country trial level conduct. This role provides leadership in the oversight and management of the three pillars of GCP Compliance as per focus above, issue management, audits & inspections as per program/trial/country\xe2\x80\x99 selection and GCO self-strategy delivery; and in providing strong support to the GCO front-line dedicated to clinical site management, strengthening GCO Operational Excellence and enabling GCO to generate reliable scientific evidence.

Your key responsibilities, but not limited to:

• Accountability for the compliance oversight and control of regulated GCO activities as per scope, focusing on Asia Hub & Country level delivery including country trial level conduct
• Oversight of the GCP Compliance support provided to the front-line dedicated to clinical site management, strengthening Operational Excellence
• Oversight of Hub & Country level quality issues, deviations and quality events management
• Oversight of audits and inspections as per program/trial/country\xe2\x80\x99 selection and scope
• Contribute to the self-assessment strategy development and accountable for its delivery
• GCO cross-functions risk assessments oversight and coordination if program/trial/country level in scope
• Lead a functional high-performance team of GCP Compliance managers with a strong focus on high quality, compliance and active risk management
• Contribute to developing a compliance culture within GCO, advocating the adherence to highest standards and ethical integrity

Diversity & Inclusion / EEO

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

Minimum Requirements

Desirable requirements:

• 8+ years industry experience, with experience in leadership positions (including matrix leadership, stakeholders\xe2\x80\x99 management, collaboration fostering to increase performance)
• Advanced understanding of drug development with experience in clinical operations and clinical site management, with an in-depth knowledge of clinical research international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable
• Strategic thinking and analytical skills; risk management and risk-based decision making knowledge and mindset
• Experienced in change management, intercultural experience, and ability to act in a complex and rapidly changing business environment
• Advanced degree in science, engineering or relevant discipline
• Project management/Risk Management
• Lean education/training, 6-Sigma

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we\xe2\x80\x99re proud of this, we know there is so much more we could do to help improve and extend people\xe2\x80\x99s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\xe2\x80\x99s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could achieve here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams\xe2\x80\x99 representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. #GCO


Division
Global Drug Development
Business Unit
GDO GDD
Location
India
Site
Hyderabad, AP
Company / Legal Entity
Nov Hltcr Shared Services Ind
Functional Area
Quality
Job Type
Full Time
Employment Type
Regular
Shift Work
No