The OMA Compliance & Governance GxP Senior Manager / Associate Director is responsible for driving and implementing an integrated Global, Regional and Local Compliance strategy to ensure adequate oversight and monitoring of Oncology Medical Affairs clinical trials including Pharmacovigilance activities as applicable (GxPs).
Within this role, he / she will ensure leadership, on-going support and guidance to the Global clinical operations franchise team, Regional and Country compliance champions within the organization to drive compliance with applicable regulatory requirements, the Novartis Quality Management System, policies & written procedures as well as implementation of Industry Best Practices, in collaboration with Global Governance and Pharma Medical Affairs as appropriate.
The position holder will contribute to the OMA organization as a member of the Compliance & Governance team to ensure consistency and deliver key strategic priorities, objectives and goals within their respective area of responsibility at Global, Regional and Local level.
He / she will also be a member of the Compliance Governance Forum by leading oversight and monitoring of GxP landscape.
1.Responsible for an effective global, regional and local implementation and improvement of the Novartis Quality Management System for Clinical Trials including Pharmacovigilance activities as applicable.
2.Provides leadership and direction to the Compliance team (global clinical operations franchise team, region and countries) for an adequate oversight and monitoring of clinical trials activities.
3.Provides input to the global clinical operations franchise team, the region and countries decision-making, prioritization of initiatives and drive consistent rollout of global initiatives related to oncology medical affairs compliance.
4.Defines and monitors global franchise clinical operations team, regional and local quality objectives in alignment with Oncology Medical Affairs global strategy and Novartis Global Quality Plan.
5.Provides expert advice and operational support and guidance to the global franchise clinical operations team, region and CPOs, performs regular country visits and runs regular one to one interactions with global, region and local champions.
6.Drives and executes change management to promote a sustainable culture and mindset of high ethical standards and compliance through quality across the global franchise clinical operations, region and CPOs and embed it into daily work.
7.Identifies opportunities to foster alignment and ownership / accountability of compliance at global, regional and local level.
8.Builds at global, regional and across countries compliance networks that allows knowledge sharing and knowledge transfer as a basis for improving compliance performance.
9.Provides actionable data to the Global Head Compliance & Governance on the state of medical compliance for his / her global franchise clinical operations team, region and countries to minimize compliance risk.
10.Oversees the management of the compliance dashboard framework & its business process for the global, regional CPOs organization, and reports areas for improvement to the Compliance & Governance Forum.
11.Ensures regular review and assessment of key performance / quality indicators at the global, regional and local level and across GxP processes.
12.Ensures that global regulated processes are adequately rolled out, trained and implemented in the global franchise team, the region and countries.
Scientific qualification (PhD, MSc or Bachelor’s Degree) in in an appropriate scientific discipline or quality-related field with an in-
depth knowledge of the international pharmaceutical product deve English A minimum of 8 years’ experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities.
Expertise in the principles and practices of Quality Risk management and / or GxP audits Strong leadership skills, able to lead an organization that is spread globally and regionally.
Proven strategic, analytical, organizational and planning skills. Strong track record in implementing strategy effectively.
Record of accomplishment of identifying and driving change to create stronger organizations and to sustain a culture of high ethical standards and compliance.
A broad understanding of Quality Management, GCP, GVP and Risk Management processes. A broad understanding of main Health Authorities standards (e.
g. FDA, EMEA) and ICH regulations and guidelines. Previous experience in a country / Regional role is desirable. Proven self-
starter with experience in building capabilities based on defined business needs