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Clinical Quality Assurance Operations Manager
NovartisBarcelona, Kingdom Of Spain, EspañaHace 7 días
Descripción del trabajoDevelop, implement, and execute CQA project management to support department resource management and on-time completion of tasks. Lead regular project update meetings with CQA personnel to track CQA projects and initiatives, time requirements for tasks, and adjustments to resources based on program needs. Provide regular updates to CQA management regarding resource activities and changing resource needs. Provide project management oversight and scheduling for CQA projects separate from DU CQA support activities. Drive a culture of quality in Development by collaborating with the business to positively impact the strategy, mission, and vision of Research and Development Quality (RDQ). Facilitate unified quality audit program (UQAP) planning in CQA; Interface with RDQ and Development line functions for CQA resource planning related to cross-department initiatives. 7 years of involvement in regulated activities (GCP / PV), clinical development and / or QA positions. Broad understanding of global Health Authority expectations in Clinical Development; Ability to work independently and in a global / matrix environment. 3 or more years’ experience in managing projects. Ability to interact with and present to senior management at all levels, external audiences, and inspectors. Strong skills in GCP, quality and / or clinical development. Strong interpersonal, communication, negotiation, and problem-solving skills. Mid-Senior level Full-time Quality Assurance Industries : Pharmaceutical Manufacturing
Overview
Clinical Quality Assurance Operations Manager
- Location : London, UK;
- Dublin, Rep of Ireland;
Barcelona, Spain. Role type : Hybrid.
As a Clinical Quality Assurance Operations Manager you will provide resource management and Quality deliverable oversight on the end-to-end Clinical Trial Process for the Clinical Quality Assurance (CQA) Process Quality and Compliance team to ensure compliance with Health Authorities requirements, internal standards, and a full adherence to patients’ safety, rights and well-being.
Responsibilities
act as CQA Responsible person for Integrated Safety Assessment (ISA) target identification and reporting.
Essential Requirements
strong understanding ofproduct development science.
Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Join our network and explore opportunities : Not the right role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as they come up.
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Quality Assurance Manager • Barcelona, Kingdom Of Spain, España
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