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- Tasks: Lead global quality processes and drive change control for impactful projects.
- Company: Cytiva, a leader in transforming human health through innovative solutions.
- Benefits: Full-time role with opportunities for career growth and skill development.
- Why this job: Make a real difference in life-saving activities and work with passionate teams.
- Qualifications: Bachelor's degree and experience in quality assurance within regulated industries.
- Other info: Join a dynamic team dedicated to advancing future therapeutics globally.
The predicted salary is between 36000 - 60000 £ per year.
Join to apply for the Principle Quality Assurance Process Specialist role at Cytiva. Be part of something altogether life-changing! Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our initiating customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
The Principle Quality Assurance Process Specialist for Cytiva is responsible for key global quality processes with a specific focus on end-to-end Change Control process that drives significant impact to the organization. This position is part of the Quality Governance Team located in Amersham or Uppsala and is on-site. At Cytiva, our vision is to advance future therapeutics from discovery to delivery.
What You Will Do
- Leadership of the end-to-end QMS change control process, providing subject matter expertise to all sites and global functions.
- Drive the standardisation & best practice of the QMS change control process across all sites and functions, covering all aspects of the product life cycle management and compliance.
- Ownership and accountability for key global change controls concerning the QMS or major quality-related changes, including leadership of the Global Cross-Functional Review Team.
- Working with the DBS tools to improve effectiveness and efficiency of other key quality processes as required, in line with the customer expectations.
- Ownership of KPIs related to Change Controls, specifically on-time completion and effectiveness checks.
- Prepare reports on KPI, identify trends and improvement opportunities.
Who You Are
- Bachelor's Degree, or equivalent experience in regulated medical device, pharmaceutical or life sciences industry.
- Quality Assurance/Quality Engineering experience in a GMP environment.
- Demonstrated good collaboration skills and expertise to effectively communicate across the organization.
- Understanding QMS and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485, and ISO 9001.
- Exceptional analytical, problem-solving & root-cause analysis skills as well as proven track record working cross-functionally and at a global level.
It would be a plus if you also possess previous experience in:
- Comprehensive understanding of electronic systems, Magic and Veeva, used to manage change control processes.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
Principle Quality Assurance Process Specialist in Little Chalfont employer: Cytiva
Contact Detail:
Cytiva Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principle Quality Assurance Process Specialist in Little Chalfont
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Cytiva. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching Cytiva's values and recent projects. Show us you’re not just another candidate but someone who genuinely cares about transforming human health.
✨Tip Number 3
Practice your answers to common interview questions, but keep it natural. We want to see your personality shine through, so don’t be afraid to let us know what makes you tick!
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you’re serious about joining our team.
We think you need these skills to ace Principle Quality Assurance Process Specialist in Little Chalfont
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Principle Quality Assurance Process Specialist role. Highlight your relevant experience in quality assurance and any specific skills that match the job description, like your knowledge of QMS and regulatory requirements.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background aligns with Cytiva's mission. Don’t forget to mention your collaborative skills and problem-solving abilities!
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just responsibilities. Use metrics where possible to demonstrate your impact, especially in areas like change control processes and KPI management.
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It’s straightforward and ensures your application goes directly to the right team. Plus, we love seeing candidates who take the initiative!
How to prepare for a job interview at Cytiva
✨Know Your QMS Inside Out
Make sure you have a solid understanding of Quality Management Systems (QMS) and relevant regulatory requirements like FDA CFR 21 820 and ISO 13485. Brush up on your knowledge about change control processes, as this role heavily focuses on them. Being able to discuss these topics confidently will show that you're serious about the position.
✨Showcase Your Collaboration Skills
Cytiva values collaboration, so be prepared to share examples of how you've worked effectively with cross-functional teams in the past. Think of specific instances where your communication skills made a difference in achieving a common goal. This will demonstrate that you can thrive in their team-oriented environment.
✨Prepare for Problem-Solving Questions
Expect questions that assess your analytical and problem-solving abilities. Prepare to discuss past challenges you've faced in quality assurance and how you approached them. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it easier for the interviewers to follow your thought process.
✨Highlight Your Continuous Improvement Mindset
Cytiva is all about continuous improvement, so be ready to talk about how you've contributed to enhancing processes in previous roles. Share specific KPIs you've worked with and any trends or improvements you've identified. This will show that you're proactive and committed to driving quality in everything you do.
