138 days ago on sjobs.brassring.com

Process Control Manager - Oncology

Novartis Pharma Schweiz AG

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Process Control Manager - Oncology

Job ID 197356BR Position Title Process Control Manager - Oncology Division PHARMA Business Unit ONCOLOGY BU - NPH Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Quality Job Type Full Time Employment Type Regular Job Description 1. Collaborate with Oncology Clinical Development (OCD) associates by supporting the implementation of new or revised processes in the Quality Plan (QP) in OCD.
2. Represent OCD and/or CTMR on cross-functional initiatives aimed at process improvement and enhanced quality implementation of new processes.
3. Responsible for metrics and reporting of OCD KQIs, Standard Operating Procedures (SOP) Deviations, OCD QP, etc to OCD and CTMR Leadership Teams as well as to associates in the OCD Line Function. Recommend corrective actions and ensure all relevant follow-up activities are completed based upon report outputs
4. Review and provide input to SOPs as needed. Collaborate effectively with associates across the Division as applicable. Support operational aspects of implementing new or revised processes in OCD to enhance clinical trial process quality. Track deviations from SOPs and ensure appropriate documentation is filed and corrective actions are taken within the OCD Line Function. .
5. Plan, perform and coordinate periodic quality control reviews of OCD processes and key deliverables by systematically sampling/monitoring adherence to SOPs and standards. Report findings to OCD and CTMR Leadership Teams as well as to associates in the OCD Line Function and provide remediation planning and support (where necessary).
6. Contribute to process training content that impacts roles within OCD {more than 450 associates}.
7. Work with the Head of Process Quality Management to address potential quality issues and emerging compliance concerns and recommend innovative solutions. Track, analyze, and report trends from Process Deviations, Quality Incidents, KQIs and KPIs and follow-up to completion all relevant remedial strategies resulting from Corrective Action Plans identified during Audits and Inspections.
8. Collaborate with ODQA and support OCD associates to have Health Authority Inspections and Audits with no observations impacting Clinical Line Function. Ensure all corrective and preventive actions are implemented as they impact OCD.
Minimum requirements • Bachelor’s Life Science Degree; advanced degree preferred
• English fluent written and spoken
• At least 5 years working experience in Clinical Development 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 •