347633BR
Jul 19, 2022
India

Job Description

400 active trials, Novartis GDQ is committed to delivering support to make the clinical trial process more efficient and patient-friendly. We are in search of those who are passionate about applying their experience to support and drive innovation with quality process.

Your responsibilities:
Your responsibilities include, but are not limited to:

• The Quality Metrics Governance Lead is responsible to define and maintain the Global Development Quality (GDQ) key metrics and key performance indicators (KPI) to enable the organization to oversee quality compliance and performance and drive process improvement initiatives.
• Drive the collaboration between Business/Line functions and Quality Assurance stakeholders to define a metrics program that is fit for purpose, value added and considered an essential management tool for identifying and mitigating risk and for continuous process and quality system improvement.
• Manage the automation of data collection for reporting, gather and review high quality and meaningful commentary and provide dashboards and regular management update reports to GDQ and GDD functions. Present KPI data and insights to senior management and independently facilitate team / management meetings to discuss quality compliance and performance.
• Responsible for discovering, interpreting, and communicating significant patterns in data to relevant stakeholders and governing boards. Manage the delivery, comprehensive oversight, and continuous improvement of the GDQ metrics program with a focus on driving standardization and simplification.
• Lead the development of innovative solutions for effective tracking, management and oversight of key governance and compliance data (Inspections, Escalations, Quality Issues, etc.).
• Manages the oversight, communications, and awareness of the status of various Compliance Activities and relevant Quality Systems within Novartis Global Development (CAPAs, Quality Issues, overdues etc.).
• Partner with the GDQ risk management teams and strengthen the operational risk management by providing data and contributing to the risk identification and mitigation discussion.
• Liaise with Quality System super users, key users and GDQ System operational associates to ensure that the systems reflect organizational needs. Promote change management and support a culture of quality, compliance, performance, and collaboration; identify opportunities for global/local alignment and for resolving issues in a timely manner

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

What you’ll bring to the role:

• A minimum of 5 – 10 years in the pharmaceutical industry or public health sector, in the area of quality, drug development, patient safety or compliance. Demonstrated experience with managing key performance metrics, including experience in data visualization and automation tools.
 Proven self-starter with experience in initiating and ensuring delivery of geographically and functionally diverse teams. Knowledge of computer information systems including data science and analytics needs assess, cost/benefit analysis, and implementation track record on global organizational level.
 Track record of successful project and process management specifically information systems projects. Excellent interpersonal, communication, negotiation, and problem-solving skills.
 Ability to present to Novartis senior management and to external audiences (e.g., at Health Authority inspections).
 Demonstrated leadership in implementing robust quality systems and setting global quality controls in a regulated area.
 Strong organizational awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross-functionally and in global and matrix teams.

Desirable:
• Degree in Business Administration, Life Sciences, Computer Information Systems, or other related discipline required

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!

Novartis is an equal opportunities employer and welcomes applications from all suitably qualified persons.

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: https://talentnetwork.novartis.com/network
Global Drug Development
QA GDD
India
Hyderabad, AP
Quality
Full Time
Regular
No
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347633BR

Quality Metrics Governance Lead

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