Job Description Summary
LOCATION: London, UK, Dublin, Rep of Ireland or Barcelona, SpainROLE TYPE: Hybrid Working, #LI-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 the Health Authorities requirements, the internal standards and a full adherence to patients’ safety, rights and well-being.
Job Description
Job Description
Developing, implementing, and executing CQA project management to support department resource management and on-time completion of tasks. The CQA Operations Manager will 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.
They will also provide regular updates to CQA management regarding CQA resource activities and changing resource needs. Lead project management oversight and scheduling for CQA projects separate from DU CQA support activities. And drive a culture of quality in Development by close business collaborating to positively impact the business and implementing the Strategy, Mission and Vision of Research and Development Quality (RDQ).
Key Responsibilities:
Use project management tools to design templates/tools for the tracking of CQA tasks and deliverables relevant to CQA Process Quality and Compliance support activities.
Support maintenance of CQA documentation, including GxP record archiving in relevant systems
Ensure maintenance of CQA training curricula in the applicable systems
Conduct regular project management meetings with CQA associates to ensure availability of current CQA resource information and program milestone dates.
Use project management tracking tools to provide regular CQA resource utilization information to CQA management.
Provide project management oversight to non-Development Unit (DU) CQA projects and workstreams to ensure timely completion of tasks and CQA resource oversight.
Facilitate unified quality audit program (UQAP) planning in CQA, act as CQA Responsible person for
Investigator Site Audit (ISA) target identification and reportingInterface with RDQ and Development line functions for CQA resource planning related to cross departmental initiatives
Essential Requirements:
+7 years of involvement in regulated activities (Good Clinical Practice (GCP)/Pharmacovigilance (PV)), clinical development and/or QA positions.
Broad understanding of global expectations of Health Authorities in Clinical Development and profound understanding of the science of product development.
Ability to work independently and in a global/matrix environment.
3 or more years’ experience in managing projects.
Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
Strong skills in GCP, quality and/or clinical development.
Strong interpersonal, communication, negotiation, and problem-solving skills.
Ability to interact with and present information to management, and diverse audiences.
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? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Skills Desired
Agility, Auditing, Audit Management, Business Partnering, Continued Learning, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, ISO 9001, Leadership, Organizational Savvy, People Management, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Stakeholder Management, Technological Expertise, Vendor Management
