Associate Director, Medical Governance & Risk Management

Novartis Farmacéutica; Barcelona; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An established industry player is seeking an Associate Director for Medical Governance & Risk Management. This pivotal role involves implementing governance frameworks, managing audits, and guiding associates in quality management. The ideal candidate will have over 10 years of experience in the pharmaceutical sector, with a strong focus on GxP processes and risk management. You'll collaborate across functions and countries, driving projects to ensure compliance and excellence in medical affairs. If you possess strategic acumen, leadership skills, and a passion for quality, this opportunity is perfect for you.

Formación

• 10+ years in the pharmaceutical industry, focusing on medical affairs and compliance.
• Strong knowledge of GxP processes and experience in audits and CAPA.

Responsabilidades

• Support the implementation of governance frameworks for medical programs.
• Facilitate connections between local and global Medical Governance Leads.

Conocimientos

GxP processes

Risk management

Quality assurance

Leadership skills

Analytical skills

Interpersonal skills

Strategic planning

Problem-solving

Educación

Bachelor's degree in Medical Sciences

Bachelor's degree in Life Sciences

Bachelor's degree in Medicine

Descripción del empleo

Associate Director, Medical Governance & Risk Management

Job ID REQ-10041551

Mar 17, 2025

Spain

Summary

The Associate Director of Medical Governance & Risk Management has a crucial role in supporting the implementation of the established unified governance framework for medical and patient-focused programs within our organization. This role is responsible for facilitating the roll-out of GxP processes, supporting self-assessments and audits, managing CAPA, and guiding associates in quality issue management. The Associate Director will actively contribute to maintaining excellence in risk and quality management within Novartis Medical Affairs.

About the Role

Major accountabilities :

• Provide support in the implementation of the established unified governance framework for medical and patient-focused programs.
• Facilitate connections between local Medical Governance Leads (MGLs) and global experts within MEOG and Global Medical Affairs (GMA).
• Assist in the development and execution of comprehensive self-assessments and controls in Medical Affairs.
• Support audits by assisting in the preparation, conduction, and management of corrective and preventive actions (CAPA).
• Guide and mentor associates in managing risks and quality issues.
• Contribute to the development and updates on GxP processes, medical policies, and guidelines.
• Stay updated on industry trends and external demands to proactively address compliance needs.
• Collaborate with cross-functional teams to drive projects and achieve outstanding results.
• Collaborate with the Medical capabilities function to ensure effective training and onboarding processes.
• Act as a key stakeholder in decision-making processes and actively participate in project teams.
• Demonstrate strong leadership skills and the ability to work across functions, countries, and cultures.
• Utilize strategic, analytical, organizational, and planning skills to support the implementation of the governance framework.
• Act as a liaison between scientific and business functions.
• Possess a strong business strategy acumen to align the medical governance and risk management with organizational goals and objectives.

Key performance indicators :

• Quality Management System standards are maintained; potential risks are identified and mitigated.
• Health Authority inspections and internal audits have no critical findings in assigned areas.

Minimum Requirements :

• Bachelor's degree in a relevant field (e.g., Medical Sciences, Life Sciences, Medicine or related fields).
• Minimum of 10 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.
• Strong knowledge of GxP processes and medical guidelines.
• Experience in self-assessments, audits, and managing CAPA.
• Ability to contribute to effective risk management and collaborative problem-solving.
• Experience in working with global teams and cross-functional collaboration.
• Proven experience in driving change and building capabilities.
• Strong track record of implementing strategy effectively.
• Excellent leadership and interpersonal skills.
• Proactive and able to quickly identify contingency plans.
• Strong strategic, analytical, organizational, and planning skills.
• Proven ability to act independently while incorporating stakeholder feedback.
• Able to influence decision-making and drive project teams for outstanding results.
• Possess facilitation skills to bridge between scientific and business functions.
• Business strategy acumen to contribute to the alignment of medical governance and risk management with organizational goals and objectives.

Languages :

• Fluent in English, both in speaking and writing.

J-18808-Ljbffr