Process Governance & Risk Manager

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 for overseeing metrics and risks for the Sandoz vigilance system. The role must ensure that Sandoz patient safety is compliant with worldwide regulations and with global line functions from all Sandoz divisions in close collaboration with Director Process Governance, Compliance & Risk.

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

• Responsible to design and drive the governance of processes owned by Sandoz and strategic suppliers and assure conformity with Sandoz group policies and worldwide regulatory requirements.
• Responsible to define, implement, and maintain leading expertise on metrics methodologies,
• Support companywide risk assessment limited to worldwide pharmacovigilance and device vigilance systems by overseeing the management and implementation of corrective and preventive actions (CAPAs).
• Support development and maintenance of efficient and uniform processes and global operating procedures (GOPs)/standard operating procedures (SOPs) to assure that worldwide regulatory requirements for marketed and development pharmaceutical products are met in consultation with relevant GOP/SOP governing body where applicable.
• Oversee Pharmacovigilance System Master File (PSMF) metrics ensuring that Sandoz group is compliant with worldwide regulations and company policies & procedures are followed.
• Collaborate with other Sandoz global line functions, and countries to develop synergies, to drive performance and quality, to identify process improvement areas as well as development of respective process changes. and ensure compliance with the Health Authority expectations.
• Ensure implementation of GOPs/SOPs at global, regional, and local levels to support consistency in policies and processes in collaboration with Quality Assurance (QA). This includes assuring proper training and communication.
• Monitor quality of safety information and compliance for all relevant processes through tracking of key performance indicators.
• Responsible for preparing and presenting regulatory compliance and risks governance during inspections (EMA, FDA, etc.)/ internal audits, and support inspection/internal audits responses.
• Drive adoption of forward-looking risk management mindset and practices including a dedicated patient safety risk register, ensuring that CMO&PS organization is properly identifying, mitigating (as required) and communicating its key risks and issues.
• Leverage digital tools and best practice from within Sandoz and externally to streamline and simplify data access, generation/oversight of metrics and risks whilst ensuring ease of accessibility of reports/data.
• Deputize for Director Process Governance, Compliance & Risk in key global leadership forums representing internal and external forums including senior leadership meetings at Sandoz.

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 >8yrs of experience in drug development, including clinical safety, pharmacovigilance, and closely related areas of development.
• ≥ Five years of global people management and development experience required.
• Sound knowledge of global safety and pharmacovigilance regulations worldwide
• Demonstrated success in resource planning and management.
• 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