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Knowledge Management Lead, Quality

Employer
Novartis
Location
Hyderabad, India
Salary
Competitive
Closing date
Jun 7, 2023

View more

Discipline
Other
Position Type
Full Time
Organization Type
Pharma

Job Details

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 Knowledge Management Lead, jointly with the accountable global process owners, is responsible for driving the interpretation, sharing and the improvement strategy of identified key needs within the organization globally. Manage the design and implementation of the above. The gathering of data in support of the above includes feeds from inspections, audits, externally received information by Health Authorities and via other quality activities and metrics, and their analysis and interpretation. Lead improvement activities based on identified key needs by providing support to leadership in driving the realization of quality improvement benefits, pro-active culture of awareness and related actions and in embedding a continuous quality improvement, self-learning mindset.

Develop and implement an integrated KM communication and progress reporting plan for key needs/improvement opportunities (e.g., lessons learned, best practice sharing, general communications) to build momentum, instill change awareness, and to keep the Quality Organization’s stakeholders fully informed, involved and engaged on all levels.
Keep senior leadership (Global Development Quality Leadership, and relevant business/QA boards such as QRB) fully informed and involved through appropriately customized (content, frequency) communications on the Knowledge Management program’s progress, successes, and development needs, including roadblocks and bottlenecks.
Interface with all relevant QA and Development business areas and functions to lead the identification of critical knowledge, development and dissemination of succinct and value-add lessons learned and related training materials.
Represent Development GCP/PV areas and Knowledge Management in the Risk Council, Metris Governance & Improvement Council, and the Global Lessons Learned Network. Establish new or leverage existing data feeds and information channels in order to lead and support the gathering of information from inspections, audits, regulatory intelligence, KPI/KQI, and other quality activities and initiatives, and ensure their successful translation into key needs and improvement opportunities for GDDQ and Global Drug Development on a global basis.
Work closely with the Quality Processes & Innovation Lead to identify new legislation which could impact on Novartis. Ensure appropriate review of the new legislation is undertaken and communicated to Group. In close collaboration with Development business functions and QA groups, lead the interpretation, analysis, and summary of quality-related data feeds/sources, identify trends/patterns, and support/monitor their remediation where required, in close collaboration with accountable global process owners.
Develop and implement an integrated communication and progress reporting plan for key needs/improvement opportunities (e.g., lessons learned, best practice sharing, general communications) to build momentum, instill change awareness, and to keep the organization’s stakeholders fully informed, involved and engaged on all levels. Keep senior leadership (GDDQ leadership, and relevant business/QA boards such as QRB) fully informed and involved through appropriately customized (content, frequency) communications on the Knowledge Management program’s progress, successes, and development needs, including roadblocks and bottlenecks.
Interface with all relevant QA and Development business areas and functions to lead the development and dissemination of succinct and value-add lessons learned and training materials. Represent Development GCP/PV areas and Knowledge Management in the Risk Council, Metris Governance & Improvement Council, and the Global Lessons Learned Network. Assist GDQ leadership in setting proactive QA priorities and targets globally for the Quality Plan based on interpretation of key needs; align with key projects and initiatives in Development QA and the Development business functions. Support a Quality Improvement Culture in Development QA and beyond by continuously broadening program reach and activities towards a pro-active culture of awareness and self-learning in the organization, fully embedded in the organization’s processes and mindset.

Diversity & Inclusion / EEO

We are 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:

• 12yrs experience in Knowledge Management in the pharmaceutical industry, preferably in quality and/or clinical development/pharmacovigilance.
• Broad understanding of relevant GxP regulations and global expectations of Health Authorities in the area of Pharma Development. Strong matrix leadership and people management skills, with ability to successfully lead and engage culturally diverse project teams.
• Extensive track record of successful project and process management work. Demonstrated leadership in implementing robust quality systems and setting global quality standards in a regulated area.
• Ability to effectively interact with and present to Senior Management at all levels, as well as to external audiences and inspectors.
• Ability to influence and drive/facilitate change across the organization. Excellent communication, negotiation, consulting/facilitation, and interpersonal skills.
• Strong organizational awareness (e.g. inter-relationships of departments, business priorities), including significant experience working cross-functionally and in global and matrix teams.
• Robust knowledge of Novartis Quality, Drug Development, Drug Safety & Medical Affairs organizations, and respective governance.

Why Novartis?
236 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!

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform 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.

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

Company

At Novartis, we are reimagining medicine.

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.

We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!

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