R&D Quality Manager

Major accountabilities:

• Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility
• Write review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Support Project management functions as a project team member.
•  Provide support to TRD line functions in GMP related topics as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).

Key performance indicators:

• Coordinate interface issue resolution between business stakeholders and IT subject matter experts
• Serve as deputy to the Business System Owner, providing backup and support for system governance
• Evaluate and approve IRT (Interactive Response Technology) exceptions based on thorough risk assessment to ensure supply continuity
• Review and approve deviations related to clinical supplies, ensuring GxP compliance
• Develop and maintain quality documentation for interface management processes
• Lead cross-functional initiatives to improve system integration and data integrity
• Represent QA in business review meetings and governance forums
• Identify opportunities for process improvement and automation