Process Governance & Risk SME

Job Description

“2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, it’s growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact! This is one such role!”

Process Governance & Risk Manager is accountable to lead activities and initiatives designed to identify and categorize risks that potentially impact vigilance system and the broader patient safety organization as well as prepare action plans for leadership endorsement. Ensure oversight of management of patient safety deviations and quality incidents in close collaboration with Director Process Governance, Compliance & Risk.

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

• Support review of emerging worldwide regulations, performing impact assessments and driving process changes required to ensure ongoing compliance to global regulatory requirements.
• Lead and support strategic projects related to process and risk management of the Sandoz vigilance system.
• Support preparation and maintenance of guidance documents and training material to educate patient safety associates on the deviation and quality incident process.
• Monitor compliance of the patient safety organization to deviation and quality incident handling processes and standards and where deficiencies are identified, develop, and implement strategies to address them.
• Collaborate with QPPV Office and other functions to produce metrics and complete trend analyses designed to identify areas of risk with impact on the vigilance system.
• Collaborate with other global line functions across and strategic suppliers to establish and meet joint accountabilities.
• Act as a subject matter expert during audits and inspections, lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
• Alert Director Process Governance, Compliance and Risk manager of potential compliance issues

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:

• Life Sciences/ Pharmacy/ Medical Sciences or equivalent degree with ≥ Five years of experience in drug development, including clinical safety, pharmacovigilance, and closely related areas of development.
• ≥ Two years of global people management and development experience required.
• Sound knowledge of global safety and pharmacovigilance regulations worldwide
• Proven ability to work and handle multiple tasks independently and effectively
• Ability to lead and deliver cross divisional initiatives.
• Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills.
• Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.
• Excellent planning, organizational and computer skills

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
How will we do this? 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 achieve here at Sandoz!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Join our Novartis Group 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