摘要
Are you ready to shape the future of medical governance at Novartis? As a recognized and standardized role within the Medical Affairs department, the Medical Governance Lead plays a pivotal part in implementing our unified governance framework across medical activities. You’ll drive excellence in GxP processes, audits, CAPA management, and quality issue resolution—ensuring scientific rigor, compliance, and risk management across the board.
If you're passionate about elevating standards and guiding teams through complex governance landscapes, with a proactive and solutions-oriented approach, this is your opportunity to make a meaningful impact.
About the Role
Key Responsibilities:
- Ensure the implementation of the established governance framework, health authority requirements, and ICH guidelines for medical GxP activities.
- Understand the systems that enables key governance processes in order to give advice and guidance to activity owners, ensuring alignment with risk and quality management practices.
- Provide governance support, advice, coaching and expert input to the MA activity owners and teams.
- Be the single point of contact for partner functions such as GGO, SSO, QA, Compliance, Safety, CDO (Clinical Disclosure Office), ERC, Procurement and others. Matter Expert in sponsor and third-party qualification.
- Promote local research, ensuring the proper classification of medical activities, in collaboration with the ERC if necessary. Support data quality/integrity in MA.
- Providing insights about value indicators (KPI, KQI) and risks (processes, requirements and L/G regulations). Maintain overview and monitor progress of R/C issues, ensure & track escalation, and follow-up until resolution
- Monitoring and giving feedback to improve processes, systems and capabilities, with clear quality and performance metrics.
- Track deviation and support implementation/resolution of local CAPA.
- Oversee and monitor local audit & inspection readiness and execution, in close collaboration with local QA and Safety Dpt.
- Proactively participate in global MGL Network for ensuring continuous improvement, to drive projects and achieve outstanding results. Support initiatives for creating stronger organizations and a culture of high ethical standards and compliance. Might lead/co-lead workstream or working group.
Essential Requirements:
- Bachelor's scientific degree, PhD or equivalent in a relevant field (e.g., Medical Sciences, Life Sciences, Medicine or related fields)
- Minimum of 5 years of experience in the pharmaceutical industry, preferably in medical affairs, clinical development, medical compliance/Governance, quality assurance, risk management, regulatory, or a related area. Experience in more than one of these areas is desirable.
- Strong knowledge of GxP processes and medical guidelines. Deep understanding of health authority requirements and ICH guidelines. Experience in self-assessments, audits, and managing CAPA.
- Experience in working with global teams and cross-functional collaboration. Demonstrated capability to work across functions.
- Possess a strong business strategy acumen to align the medical governance and risk management with organizational goals and objectives.
- Strong leadership and strategic skills, with proven experience in driving change, influencing decisions, and fostering a culture of compliance and ethical standards.
- Effective problem-solving and collaboration abilities, including risk management, conflict resolution, and a pragmatic, solution-oriented mindset.
- Fluent in Spanish and English languages, both in speaking and writing.
Benefits and Rewards:
Company Pension Plan, Life and Accidental Insurance, Meals Allowance or Canteen in the office, Flexible working hours. Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
Commitment to Diversity and Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
