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Head e-Compliance DDIT Commercial & Development

Head e-Compliance DDIT Commercial & Development

NOVARTIS

15 - 20 years

45 - 50 Lacs

hyderabad

Posted:None| Platform:

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head business development change management manager quality assurance development manager quality systems consulting data integrity risk management monitoring auditing

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Job Type

Full Time

Job Description

Summary

Lead DDIT, Commercial and Development eCompliance Team in the development and implementation of eCompliance Strategy for DDIT, Commercial and Development.
Modernizes technology, and enhances Quality Assurance oversight within DDIT, Commercial and Development in line with GxP requirements Identifies, measures, remediates, and monitors regulatory risks associated with eCompliance in DDIT, Commercial and Development in line with GxP requirements. Collaborates with eCompliance stakeholders, cross-functional partners, Data Integrity colleagues, and key stakeholders while employing strategic thinking to drive initiatives forward. Drive the AI readiness and competency building for the E-Compliance organization by identifying and ensuring training staff on AI technologies, integrating AI with existing compliance systems, and ensuring data integrity and security.

About the Role:

Lead DDIT, Commercial and Development eCompliance Team in the development and implementation of eCompliance Strategy for DDIT, Commercial and Development.

Modernizes technology, and enhances Quality Assurance oversight within DDIT, Commercial and Development in line with GxP requirements

Identifies, measures, remediates, and monitors regulatory risks associated with eCompliance in DDIT, Commercial and Development in line with GxP requirements.

Collaborates with eCompliance stakeholders, cross-functional partners, Data Integrity colleagues, and key stakeholders while employing strategic thinking to drive initiatives forward.

Drive the AI readiness and competency building for the E-Compliance organization by identifying and ensuring training staff on AI technologies, integrating AI with existing compliance systems, and ensuring data integrity and security.

Key Responsibilities:

Strengthens QA oversight of the IT activities within DDIT, Commercial and Development, including preparing for regulatory inspections and ensuring ongoing inspection readiness.
Develops a future-focused strategy in AI and emerging technologies readiness, evaluating regulatory requirements and developments to ensure Novartis QMS is fit for purpose in the eCompliance environment.
Establishes robust risk management strategies covering all areas of eCompliance for Technical Operations. Ensures that eCompliance risks are captured in Enablon/iRisk and escalated accordingly.
Provides leadership for quality systems oversight and the management of GxP computerized systems. Collaborates effectively with Quality & IT business partners in DDIT, Commercial and Development, eCompliance personnel across Novartis, and other divisional quality and business functions to ensure the delivery of quality outcomes.
Functions as a quality system owner for CSV within the Novartis Quality Manual.
Provides quality inputs into IT-related vendor selection, qualification, and management processes.
Establish governance model for continuous feedback, engagement and to drive simplification through standardization. Establish pro-active eCompliance monitoring & reporting based on a. Audit & inspection findings b. DI challenges and c. NVS functional level eCompliance related challenges
Strengthen external collaborations to get Industry benchmarking and to get more insights on the new regulatory requirements and Health Authority expectations for the computerized systems, proactively identify them and get them adapted into the internal processes and systems.

Essential Requirements:

A minimum of 15 years of relevant experience, specifically within regulated functions such as Quality Compliance, and/or IT.
Profound understanding of global regulations governing the lifecycle management of computerized systems, and how they apply to new technologies such as AI.
Strong leadership presence, with a proven ability to effectively communicate, interact and influence key stakeholders without hierarchical authority.
Excellent communication, negotiation, consulting/facilitation, and interpersonal skills.
Outstanding facilitation skills for bridging between scientific and business stakeholders, and for man-aging effective and successful international and cross-divisional collaborations.
Strong change management abilities.
Demonstrated strength in applying strategic thinking, scenario evaluation and contingency planning.
Strong organizational awareness and business acumen (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global and matrix teams.

Desirable Requirements:

Extensive knowledge of Regulatory and Quality requirements in the area of CSV.
Strategic thinking and creative problem-solving skill
Self-motivated with a high degree of ownership and accountability for results.

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Head e-Compliance DDIT Commercial & Development