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- Tasks: Lead quality assurance for innovative radiopharmaceuticals and ensure compliance in clinical trials.
- Company: Join GE HealthCare, a leader in healthcare technology and innovation.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and collaboration.
- Why this job: Make a real impact in healthcare while developing your expertise in a supportive culture.
- Qualifications: Requires significant experience in Quality & Life Sciences; Master's degree preferred or relevant experience.
- Other info: Be part of a diverse team committed to quality and regulatory excellence.
The predicted salary is between 36000 - 60000 £ per year.
As QA Manager – Pharma Services at GE HealthCare you will have a multifaceted role, ensuring the quality and compliance in the supply of novel diagnostic radiopharmaceuticals.
The role will involve the supply of GE HealthCare radiopharmaceuticals to various pharma collaborators in support of their clinical trials. You will be involved in the technology transfer of these novel agents into various contract manufacturing organisations as well as provide quality oversight of the contract manufacturing organisations. You will participate in internal and external audit. You will ensure inspection readiness and compliance with cGMP and other regulatory requirements by maintaining accurate and up-to-date quality documentation., * Act as primary quality contact with Pharma collaborators in support of supply of GE HealthCare diagnostic agents to their clinical studies
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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.
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Participate in internal and external audits and inspections and host inspections from Pharma collaborators.
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Ensure inspection readiness and compliance with cGMP and other regulatory requirements.
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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.
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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.
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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.
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Impacts approaches, projects and programs in the functional area or affected business organization and ways of working.
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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.
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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).
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In-depth knowledge of pharmaceutical facilities, manufacturing and laboratory systems
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Experience in technology transfer
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Sound knowledge of international regulatory, cGXP requirements, and best practices, including EU and FDA GMP guidelines.
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Experience in performing qualification and routine monitoring audits of suppliers.
Inclusion and Diversity
QA Manager - Pharma Services employer: GE Healthcare
Contact Detail:
GE Healthcare Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Manager - Pharma Services
✨Tip Number 1
Familiarize yourself with the latest cGMP and regulatory requirements relevant to the pharmaceutical industry. This knowledge will not only help you in interviews but also demonstrate your commitment to quality and compliance.
✨Tip Number 2
Network with professionals in the QA and Pharma Services field. Attend industry conferences or webinars where you can meet potential colleagues and learn about the latest trends and challenges in quality management.
✨Tip Number 3
Prepare to discuss specific examples of your experience with technology transfer and audits. Being able to articulate your past successes and how they relate to the role will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to influence and communicate complex information effectively. Think of scenarios where you've successfully navigated difficult conversations or built consensus, as these skills are crucial for the QA Manager role.
We think you need these skills to ace QA Manager - Pharma Services
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the QA Manager position at GE HealthCare. Understand the key responsibilities, such as ensuring compliance with cGMP and participating in audits, so you can tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in Quality & Life Sciences, particularly in pharmaceutical settings. Mention any specific instances of technology transfer, compliance activities, or audit participation that align with the job requirements.
Showcase Your Skills: Demonstrate your ability to communicate complex information effectively and your experience in influencing others. Provide examples of how you've built consensus or led projects in your previous roles, as these skills are crucial for this position.
Tailor Your Application: Customize your cover letter to reflect your understanding of GE HealthCare's mission and values. Discuss how your background and expertise can contribute to their quality culture and compliance objectives, making it clear why you're a great fit for the team.
How to prepare for a job interview at GE Healthcare
✨Showcase Your Quality Expertise
Make sure to highlight your in-depth knowledge of pharmaceutical facilities and manufacturing systems. Be prepared to discuss specific experiences where you ensured compliance with cGMP and other regulatory requirements.
✨Demonstrate Your Audit Experience
Since the role involves participating in internal and external audits, share examples of your past audit experiences. Discuss how you prepared for these audits and any challenges you overcame during the process.
✨Communicate Effectively
As a QA Manager, you'll need to communicate complex messages clearly. Practice explaining difficult concepts in simple terms, and be ready to demonstrate your influencing skills during the interview.
✨Prepare for Technical Questions
Expect questions related to technology transfer and quality management systems. Brush up on your technical knowledge and be ready to discuss how you've applied it in previous roles, especially in relation to international regulatory standards.
