At a Glance
- Tasks: Lead QA for new product launches and ensure compliance in a global manufacturing network.
- Company: Join GE HealthCare, a leader in innovative medical technology.
- Benefits: Competitive salary, travel opportunities, and a focus on professional growth.
- Other info: Collaborative environment with strong emphasis on inclusion and diversity.
- Why this job: Make a real impact in healthcare by ensuring quality in groundbreaking products.
- Qualifications: Degree in Life Sciences and experience in Quality Assurance required.
The predicted salary is between 55000 - 65000 £ per year.
Overview
We are seeking a Lead QA Specialist – New Product Implementation to provide Quality Assurance leadership for the introduction of new products across a global external manufacturing network.
In this role, you will lead QA oversight of technology transfer to Contract Manufacturing Organizations (CMOs) and support external partners manufacturing products for GE Health Care-sponsored clinical trials and pharmaceutical partner studies.
You will work in a highly collaborative, cross‑functional environment, ensuring compliant, right‑first‑time delivery of new product introductions.
Responsibilities
- Provide QA oversight for new product introduction (NPI) activities, ensuring compliance with GMP and regulatory requirements.
- Lead QA support for technology transfer to CMOs, including review and approval of protocols and risk assessments.
- Ensure external manufacturing sites are inspection‑ready and compliant.
- Act as QA lead for external manufacturing partners, ensuring adherence to quality standards and agreements.
- Review and approve GMP documentation including batch records, deviations, CAPAs, and validation reports.
- Monitor CMO performance through quality metrics, audits, and governance processes.
- Provide QA oversight for manufacture of investigational medicinal products (IMPs) supporting clinical trials.
- Support supply of products to pharmaceutical partners for clinical studies.
- Act as QA interface during client audits and health authority inspections.
- Partner with global cross‑functional teams to deliver NPI programs.
- Contribute to project governance, risk management, and decision‑making.
- Review documentation ensuring it is clear, accurate, and inspection‑ready.
- Apply Quality Risk Management (QRM) principles to mitigate risks.
- Support deviation management and CAPA implementation.
- Drive continuous improvement of NPI and external manufacturing quality processes.
- Conduct on‑site visits to CMOs to support technology transfer and QA oversight.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related discipline.
- Experience in Quality Assurance within a GMP‑regulated environment.
- Experience in NPI, technology transfer, validation, or external manufacturing.
- Experience working with Contract Manufacturing Organizations (CMOs).
- Knowledge of global regulatory requirements (FDA, EMA, ICH).
- Desired Characteristics
- Ability to work in a global, cross‑functional matrix environment.
- Strong stakeholder management and influencing skills.
- Solid understanding of GMP and quality systems.
- Strong problem‑solving and risk‑based decision‑making skills.
- Excellent written and verbal communication skills.
- High attention to detail and strong compliance mindset.
- Travel Requirements
This role requires travel (approximately 10–25%) to support external manufacturing activities, audits, and technology transfer.
Inclusion & Diversity
GE Health Care is an Equal Opportunity Employer where inclusion matters.
Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world‑changing realities.
Relocation Assistance
No relocation assistance is provided.
Company Values
At GE Health Care, we see possibilities through innovation.
We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions.
Better tools enabling better patient care.
#J-18808-Ljbffr
QA Specialist - NPI in Chalfont St Giles employer: MS0160 GE Healthcare Limited
At GE HealthCare, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. As a Lead QA Specialist in New Product Implementation, you will have the opportunity to work with cutting-edge technology in a global environment, ensuring compliance and quality in healthcare solutions. We are committed to your professional growth, providing continuous learning opportunities and a supportive atmosphere where your contributions can make a real impact.
Contact Details:
MS0160 GE Healthcare Limited Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land QA Specialist - NPI in Chalfont St Giles
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like MS0160 GE Healthcare Limited. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like MS0160 GE Healthcare Limited.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like MS0160 GE Healthcare Limited. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what MS0160 GE Healthcare Limited is looking for. A tailored application can really make you stand out!
We think you need these skills to ace QA Specialist - NPI in Chalfont St Giles
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at MS0160 GE Healthcare Limited!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show MS0160 GE Healthcare Limited that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at MS0160 GE Healthcare Limited!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At MS0160 GE Healthcare Limited, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at MS0160 GE Healthcare Limited
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at MS0160 GE Healthcare Limited that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with MS0160 GE Healthcare Limited’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
