Responsible for the implementation of enhanced line function excellence and standards including tracking progress to Key Quality Indicators (KQIs), Quality Plan and overall compliance to applicable processes and regulations. Lead initiatives within Global Medical Affairs (GMA) to support process improvement and quality performance to proactively identify and address areas of concerns to avoid downstream issues. Assist the Head of GMA and the Head of GMA Operations to drive a quality and process improvement mindset within the different line functions of GMA.
1. Collaborate with ODQA and support the implementation of the Quality Plan in GMA, including Corrective Actions and Preventative Actions (CAPA).
2. Create, track, report and follow-up to a timely completion all relevant remedial strategies resulting from Corrective Action Plans identified during Audits, SOP deviations, KQI results, ....
3. Responsible to track and report on GMA Key Quality Indicators (including among others timely CSR completion, registration of protocols and trial results to appropriate registries and required training). Recommend corrective actions and ensure all relevant follow-up activities are complet-ed based upon report outputs. With the Head of GMA, define additional KQI as needed.
4. Represent GMA on cross-functional initiatives aimed at process improvement and ensure a com-pliance focused environment.
5. Drive change management activities related to the implementation of new processes or organiza-tional changes in GMA.
6. Ensure timely input to SOPs either directly or via assigned GMA SMEs and support operational aspects of SOP training assignments for GMA. Track deviations from SOPs and ensure appropri-ate documentation is filed, analysis is performed and corrective actions are taken.
7. Systematically sample/monitor adherence to SOPs and standards and plan, perform and coordinate periodic quality control reviews of GMA processes and key deliverables. Report findings and provide remediation planning and support to management and ODQA as appropriate.
8. Implement, manage, track and oversee mandatory training programs for GMA (SOPs and GMA training curricula).
9. Work with the Head of Operations to address potential quality issues and ensure potential quality issues and emerging compliance concerns are escalated to Head of GMA and ODQA as appropri-ate.
Life Science Degree. Advanced degree preferred
- At least 8 years of global clinical trial management experience and demonstrated experience in quality management, quality improvement, or GCP auditing
- Strong understanding of regulation and guidance for drug studies including: ICH guidelines on GCP (E6, E2A and E8) and applicable regulatory requirements, specifically 21CFR sub-parts 50, 54, 56, 312 and 314 as well as the European Directives on GCP (2001/20/EC and 2005/28/EC)
- Experience leading or participating in process improvement initiatives
- Strong Clinical Research Operational knowledge and practical experience at a global level
- Experience contributing to or authoring SOPs
- Strong problem-solving skills and fast action orientation capable of quickly identifying contingency plans
- Strong skills to facilitate/ optimize contribution of team members as individuals and members of a cohesive team
- Strong capacity for working independently with minimal guidance
- Able to make & communicate difficult decisions
- Ability to work effectively in a matrix cross-functional environment
- Proficiency / Fluency in English
- Strong written and verbal communication skills
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
This position will be filled at a level commensurate with experience.
About Novartis Oncology:
At Novartis Oncology, our employees worldwide share a common mission: discover and develop innovative medicines to fight cancer. We are passionate about providing a broad range of new remedies and practical solutions that change the way patients live with cancer. In the last five years, Novartis Oncology products have helped improve, extend, and save the lives of more than 2 million people with breast cancer, chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), multiple myeloma, prostate cancer, carcinoid syndrome, and other cancers. With more than 7800 employees operating in over 50 countries, Novartis Oncology has a truly global reach. We have the advantage of extraordinarily talented and globally diverse employees who, through shared goals and different perspectives, are dedicated to improving and extending the lives of patients around the world.
Novartis Awards and Recognition :
- Working Mother?s 100 Best Companies 2012 and 2013
- Barron's World?s Most Respected Companies 2012 and 2013
- Fortune?s World?s Most Admired Companies 2012 and 2013
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