Principal Quality and Compliance Lead

Jul 12, 2021

Job Description

500+ clinical trials. The Business Excellence (BEx) group ensures smooth operations and governance of these clinical trials and innovative solutions within the Data Operations (Data Management, Database Development, Standards, Reporting, Statistical Programming) team. This also includes driving continuous improvement by monitoring effectiveness across cost / quality / productivity / speed of Data Operations ()DO activities, efficiently deploying resources & vendors oversight.
As a team member you will have the opportunity to play a key role in providing leadership within DO & closely collaborating with other line teams in Novartis for Process Improvements, Quality Compliance with innovative solutions, Training, Finance oversight and DO metric oversight to drive operational excellence. This team drives developing and implementing data analyses, data collection systems and other strategies that optimize statistical efficiency and quality.
Job Purpose
The Principal Quality & Compliance Lead, leads quality deliverables within platform, franchise or therapeutic area. Drives participation and inputs within Data Operations (DO), and cross functionally where applicable, in the delivery of quality data and programs, processes and documentation which satisfies regulations and aligns with industry best practices for Data Management and Statistical Programming (Data Operations). Develops simple and reproducible strategies to ensure quality deliverables, and enables organization to be agile and deliver timely to drug development programs.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Plan, lead and implement DO Quality & Compliance within platform, franchise or therapeutic area. Accountable for all quality related aspects within remit to ensure full compliance to all applicable global regulatory requirements is maintained and business objectives are achieved.
• Leads discussions with internal stakeholders and partners across and outside GDD in support of quality deliverables.Leads DO and Q&C towards agreed deliverables, proactively addressing potential issues before they become problematic
• Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response.Actively participate in Q&C Team and partners with organization to progress DO towards industry best practices, simplification, agility and deliverable effectiveness.
• Manages and measures quality within platform, franchise or therapeutic area. Build and maintain strong partnerships within GDD with special focus within Data Management, Statistical Programming, Statistics, Clinical and Qualitly functions.
• Lead independently or participate in improvement initiatives and/or non-clinical projects.Coordinates exception requests, deviations and corrective/preventative action plans for corresponding processes, systems and deliverables.Lead/participate and keep current in Industry regulations and requirements. Ensure Novartis participation in industry regulation initiatives (i.e. ICH, GCP, etc.)
• Ensure relevant SOPs/Working practices/trainings are in place with timely training and adherence cross functionally. Proactively reviews existing processes and identify opportunities for improvement.Represent Quality and Compliance regarding requirements and evaluation of systems that directly relate to DO or quality activities.
• Ensures DO at Novartis is considered as industry leading internally and externally; lead, influence, collaborate and proactively shape the external environment including regulatory guidelines, industry practices and professional organizations.

Diversity & Inclusion / EEO

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

Minimum Requirements

• Bachelor’s degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred Post-graduate university or college degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent with at least 7 years of experience in global drug development, within the pharmaceutical or device industry
• Significant relevant experience and knowledge in the Pharmaceutical or Device Industry.Expert in regards to regulatory requirements relevant to Data Management and Statistical Programming (e.g. GCP, ICH).
• A demonstrated expert in Data, Programming and Process Quality, providing guidance, mentoring and support to DO Organization.
• Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships.
• Outstanding verbal and written skills.
• Proven ability to proactively identify issues, recommend and implement solutions

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s 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’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s 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:
Global Drug Development
Hyderabad, AP
Research & Development
Full Time
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Principal Quality and Compliance Lead

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