Job Description Summary

As QA Manager - Research & Development at GE Healthcare you will have a multifaceted role, ensuring the quality and compliance in the development of novel diagnostic radiopharmaceuticals.
The role will involve the qualification and technology transfer of GE HealthCare radiopharmaceuticals into contract manufacturing organisations for supply to various clinical studies. You will participate in internal and external audits and inspections. You will ensure inspection readiness and compliance with cGMP and other regulatory requirements by maintaining accurate and up-to-date quality documentation.

This position will require 15-20% travelling globally.

Job Description

Responsibilities

• Work with R&D, Supply Chain and other departments to qualify and support technology transfer of GE HealthCare manufacturing processes into contract manufacturing organisations (CMOs) for supply of product to various clinical studies. Will be responsible for quality oversight of approved CMOs.Participate in internal and external audits and inspections

• Ensure inspection readiness and compliance with cGMP and other regulatory requirements.

• Create a Quality culture by driving compliance activities in the development of GE Healthcare novel radiopharmaceutical products. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE HealthCare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.

• Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource. Contribute towards strategy and policy development, and ensures delivery within area of responsibility.

• Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.

• Impacts approaches, projects and programs in the functional area or affected business organization and ways of working.

• Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.

Required Qualifications/Experience

• This role requires significant experience in the Quality & Life Sciences Quality. Knowledge level is comparable to a Master's degree from an accredited university or college ( or a high school diploma with relevant experience).

• In-depth knowledge of pharmaceutical facilities, manufacturing and laboratory systems

• Experience in technology transfer

• Sound knowledge of international regulatory, cGXP requirements, and best practices, including EU and FDA GMP guidelines.

• Experience in performing qualification and routine monitoring audits of suppliers.

Additional Information