Research and Development Quality Specialist

R&D Quality Specialist

Job Description Summary

Perform standard activities and routine quality tasks in accordance with applicable procedures. Support departmental projects and objectives within the agreed area of competency, ensuring delivery to defined timelines and quality standards. Promote and support adherence to cGMP and overall GxP compliance within TRD, in line with the Novartis Quality Management System.

Job Description

Major Accountabilities:

• Support general compliance activities in line with departmental needs (e.g., act as SOP manager, training responsible person, 1QEM key user; support KQI reporting and quality monitoring, and QMS implementation).   

• Support third party management–related processes, including administrative and system support (e.g. site ID creation, system verifications, dashboards, data management, due‑date tracking and communications).

• Support third party oversight related activities, including audit administration review of third-party GMP documentation and BD&L deals.

• Author and review GxP documentation.

• Support the filing and archiving of GxP records in accordance with applicable procedures.

• Contribute to continuous improvement of compliance and third-party management processes.

• Support project-related activities (e.g., developing new tools and implementing new processes).

Work Experience:

• Quality compliance & Quality Management Systems (GxP; strong GMP focus).

• Third-party quality management & oversight (qualification, documentation review, audit support, issue follow-up).

• Drug development / R&D exposure (preferred).

• Corrective and Preventive Action (CAPA) knowledge

English.

Skills Desired

Business Partnering, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge, Risk Management, Stakeholder Management

Experience Level

Mid Level