At a Glance
- Tasks: Support and enhance Jazz's electronic Quality Management System for better user experience.
- Company: Join a global biopharma leader dedicated to transforming patient lives.
- Benefits: Enjoy flexible paid vacation, medical insurance, and a retirement savings plan.
- Other info: Be part of a diverse team with opportunities for continuous improvement.
- Why this job: Make a real impact in the pharmaceutical industry while working remotely.
- Qualifications: Bachelor's degree and 8 years of experience in regulated industries required.
The predicted salary is between 65000 - 75000 £ per year.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families.
We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options.
We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.
Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.
Please visit www. jazzpharmaceuticals. com for more information.
The Senior Quality Systems Specialist supports the administration, governance, and continuous improvement of Jazz's electronic Quality Management System (e QMS).
The role partners with internal stakeholders and external vendors to maintain system compliance, reliability, and effectiveness while driving enhancements that improve the user experience and support business objectives.
Essential Functions/Responsibilities
- Function as a Business Administrator of the e QMS system
- Maintain the validated state of the global e QMS, troubleshooting, investigating, and escalating issues that impact system performance.
Partner with IT, Compliance, and business stakeholders to ensure timely resolution.
- Collaborate with platform vendors and Level 2 support teams to ensure timely issue resolution while maintaining appropriate cost controls.
- Provide support for Veeva Quality Suite and Jazz releases of changes to the system, ensuring the system functions as expected and all affected stakeholders are informed
- Manage the Super User group to ensure they are consistently informed of all system developments.
- Own the administration of the Good Idea Process, ensuring requests are evaluated, prioritized, and communicated to stakeholders in a timely manner.
- Analyze user feedback, identify opportunities for system enhancements, and support continuous improvement initiatives to maintain compliance and improve system effectiveness.
- Oversee the Good Idea Process to ensure that requests are properly evaluated and outcomes are communicated in a timely and efficient manner.
- Ensure that all procedural documents supporting the Business Administration role are accurate, up-to-date, and in compliance with relevant standards
- Be a key member of company audit team during regulatory or customer audits
- Generate Veeva Quality Support metrics and prepare presentations suitable for Senior Management review
- Proactively look for continuous improvement opportunities within the VQS
- Required Knowledge, Skills, And Abilities
- Bachelor's degree in Science, Engineering, Quality, or a related discipline.
- Minimum of 8 years of experience within the pharmaceutical, biotechnology, or regulated industry environment.
- Experience administering and supporting electronic Quality Management Systems (e QMS).
- Veeva Quality Vault Business Administrator training and certification, or equivalent experience.
- Strong understanding of Gx P requirements and computerized system compliance.
- Demonstrated ability to work independently and manage multiple priorities in a fast-paced environment.
- Excellent verbal, written, and presentation communication skills.
- Proven problem-solving, stakeholder management, and continuous improvement capabilities
- Required/Preferred Education And Licenses
- Typically, Bachelor’s degree in science or related discipline
- Business & Administration qualifications
- Knowledge of Quality Systems in the Pharmaceutical Industry, including digital cloud systems for Quality Management
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.
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Senior Quality System Specialist (Maternity leave cover) Remote / Home Based employer: Jazz Pharmaceuticals
Jazz Pharmaceuticals is an exceptional employer, offering a dynamic work environment in Dublin, Ireland, where innovation meets patient care. With a strong commitment to employee development and a collaborative culture, we empower our team members to contribute to life-changing medicines while enjoying comprehensive benefits and growth opportunities. Join us to be part of a mission-driven organisation that values diversity and fosters a supportive atmosphere for professional advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Quality System Specialist (Maternity leave cover) Remote / Home Based
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We think you need these skills to ace Senior Quality System Specialist (Maternity leave cover) Remote / Home Based
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 Jazz Pharmaceuticals!
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 Jazz Pharmaceuticals 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 Jazz Pharmaceuticals!
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 Jazz Pharmaceuticals, 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 Jazz Pharmaceuticals
✨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 Jazz Pharmaceuticals 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 Jazz Pharmaceuticals’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.
