At a Glance
- Tasks: Manage and enhance Jazz's electronic Quality Management System for compliance and user experience.
- Company: Join Jazz Pharmaceuticals, a global leader in biopharma dedicated to transforming patient lives.
- Benefits: Enjoy medical, dental, vision insurance, retirement plans, and flexible paid vacation.
- Other info: Be part of a diverse team committed to innovative therapeutics and continuous improvement.
- Why this job: Make a real impact in the biopharma industry while working remotely.
- Qualifications: Bachelor's degree and 8 years of experience in regulated industries required.
The predicted salary is between 60000 - 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.
The Senior Quality Systems Specialist supports the administration, governance, and continuous improvement of Jazz's electronic Quality Management System (eQMS). 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- Support the business by assuming responsibility as Business Administrator for the company digital Quality Management System (eQMS) including all functionality.
- Maintain the validated state of the global eQMS, 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.
- 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 (eQMS).
- Veeva Quality Vault Business Administrator training and certification, or equivalent experience.
- Strong understanding of GxP 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.
- 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.
Senior Quality System Specialist (Maternity leave cover) Remote / Home Based in Donaghadee 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 in Donaghadee
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Jazz Pharmaceuticals.
We think you need these skills to ace Senior Quality System Specialist (Maternity leave cover) Remote / Home Based in Donaghadee
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Jazz Pharmaceuticals.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Jazz Pharmaceuticals. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Jazz Pharmaceuticals
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Jazz Pharmaceuticals.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Jazz Pharmaceuticals achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
