Director, Medical Governance & Risk Management

Job Description Summary

Job Description

Responsibilities:

• Implement a unified governance framework for medical and patient-focused programmes ensuring consistency and compliance.

• Lead the centralised Medical Excellence Governance Board (MEGB) to streamline consultation and escalation pathways for Medical Affairs.

• Build and maintain a governance network across GlobalRegional and Country Medical Affairs enabling knowledge sharing and joint problem-solving.

• Onboard support train coach and mentor country Medical Governance Leads (MGLs) ensuring a strong and knowledgeable team.

• Develop and execute comprehensive self-assessment strategies and controls analysing trends and providing insights for continuous improvement.

• Guide and mentor associates in managing risks and issues leading investigations and overseeing CAPA for end-to-end resolution.

• Proactively identify compliance gaps and lead cross-functional projects to address and mitigate risks ensuring proper documentation and remediation.

• Coordinate audits and manage corrective and preventive actions (CAPA) according to the annual quality audit plan.

• Lead and monitor implementation of quality objectives in alignment with global strategy and quality plans.

• Represent the organization at cross-divisional committees forums and boards ensuring alignment and compliance in global projects.

Essential Requirements

• Masters degree in a relevant field (e.g. Medical Sciences Life Sciences Medicine or related fields).

• Extensive relevant work experience (15 years) across multiple medical programme or study areas or diverse expertise in clinical public health or pharmaceutical industry (including medical affairs clinical development compliance quality assurance risk management regulatory). Experience in more than one of these areas is required.

• Deep understanding of health authority requirements ICH guidelines GxP processes and medical guidelines.

• Proven experience in leading self-assessments audits and CAPA management.

• Experience working with global teams cross-functional and cross-divisional collaboration including country and/or regional roles.

• Proven ability to drive change build capabilities and sustain a culture of high ethical standards and compliance.

• Excellent leadership interpersonal problem-solving negotiation and conflict resolution skills.

• Excellent English language skills both written and spoken.

Desirable Requirements

• Externally focused to ensure awareness of trends and proactively address needs based on external demands.

• Strong strategic analytical organisational and planning skills with business strategy acumen to align governance and risk management with organisational goals.

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.

Skills Desired