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- Tasks: Lead quality assurance for pharmacovigilance systems and ensure compliance with regulations.
- Company: Join a global leader in healthcare innovation with a focus on quality.
- Benefits: Remote work, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in patient safety and quality assurance in a dynamic environment.
- Qualifications: Experience in pharmacovigilance or quality assurance; strong communication skills.
- Other info: Opportunity for travel and collaboration with diverse teams.
The predicted salary is between 36000 - 60000 £ per year.
The Manager, Clinical and Pharmacovigilance Quality Assurance for Pharmacovigilance (PV) system is a significant contributor to Global Quality and is responsible for coordinating activities to regularly verify that Jazz PV system Vendors, commercial partners and Jazz Global R&D/Quality and other teams are operating in line with applicable regulations, industry standards, Jazz policies, procedures, and quality standards in support of the Quality Management System & PV system.
In addition, the Manager will support Global Quality/ R&D leaders in providing strategic input and tactical implementation for pharmacovigilance system activities and projects, identify and communicate compliance risks, oversee action plans to mitigate risks (if applicable), and be actively involved in inspections and inspection-readiness activities. This person will participate in interdepartmental teams meetings and at times may be asked to perform activities to support other GxP areas, quality operations, and global quality systems.
Essential Functions- Gain and maintain professional expertise and knowledge of local and international regulations relative to pharmacovigilance system and quality.
- Contribute to the execution of Global PV system audit strategy, and implementation within the Quality Management System.
- Perform reviews on internal and external SOPs; participate in the development of SOPs for Quality or PV System stakeholders.
- Support updates of the quality related sections in the Pharmacovigilance System Master File (PSMF) or similar documents.
- Perform execute and evaluate PV-System auditee risk assessments.
- Coordinate and implement strategic audit plans for pharmacovigilance system activities that include service providers, vendors, business partner, and internal audits.
- For pharmacovigilance system audits conducted directly by Jazz personnel or conducted by a vendor on behalf of Jazz (external audits) participate as auditor/co-auditor and/or manage the relationship with the vendor.
- Present QA findings/observations to in-house staff and, if appropriate, to the responsible service provider, vendor, or partner company.
- Contribute to the evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.
- Participate in inspection readiness and inspections as assigned. May perform one or more inspection roles during an inspection (e.g. inspection readiness training, runner, scribe, backroom lead, SME preparation, QA checks, etc.).
- Identify and escalate critical quality issues to senior Quality management.
- Contribute to the development of continuous quality process improvements and the identification of identifying root causes for investigations and effectiveness checks if appropriate.
- Represent CPVQA within interdepartmental teams / project groups and innovation projects.
- Maintain current training in accordance with the training curriculum.
- This position may require up to 30% travel.
- Established Pharmacovigilance or Quality professional.
- Strong GVP knowledge & expertise.
- Excellent written and verbal communications skills.
- Ability to work in an entrepreneurial and fast-paced culture.
- GVP auditing experience is preferred.
- GVP lead auditor certification is desirable.
- Self-directed and ability to take action as needed with oversight.
- Ability to collaborate and partner with various internal and external business partners.
- Ability to work in a team environment.
- Disciplined, detail orientated, and strong time management skills.
- Knowledge of post-authorization commitment requirements is preferred (Phase IV, PASS Studies) and Managed Access Programs (PSPs/MRPs, Early access etc.) is desirable.
- Knowledge and experience with GCP, GLP, and GDP is a plus.
- Inspection experience with FDA, MHRA (or other EU Competent Authorities); experience with emerging markets Regulatory Authority such as PMDA a plus.
- Bachelor’s degree in a related field is required; Master’s degree in management, leadership or scientific discipline a plus.
Manager CPVQA - 1 Year FTC (Remote UK & Ireland) employer: Jazz Pharmaceuticals
Contact Detail:
Jazz Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager CPVQA - 1 Year FTC (Remote UK & Ireland)
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance and quality assurance fields on LinkedIn. Join relevant groups and participate in discussions to get your name out there and show off your expertise.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GVP regulations and quality management systems. Be ready to discuss how you've tackled compliance risks in the past and how you can contribute to Jazz's goals.
✨Tip Number 3
Don’t just wait for job openings to pop up! Keep an eye on our website and apply directly through it. This shows your enthusiasm and makes it easier for us to track your application.
✨Tip Number 4
Follow up after interviews with a thank-you email. Mention something specific from your conversation to remind them of your fit for the role. It’s a small gesture that can make a big difference!
We think you need these skills to ace Manager CPVQA - 1 Year FTC (Remote UK & Ireland)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight your expertise in pharmacovigilance and quality assurance, and don’t forget to mention any relevant certifications or experiences that make you stand out!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the Manager CPVQA role. Share specific examples of your past work that align with the responsibilities listed in the job description.
Showcase Your Communication Skills: Since excellent written communication is key for this role, ensure your application is clear, concise, and free of errors. Use professional language but keep it friendly – we want to see your personality shine through!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details you need about the role and our company culture there!
How to prepare for a job interview at Jazz Pharmaceuticals
✨Know Your Regulations
Make sure you brush up on local and international pharmacovigilance regulations. Being able to discuss these confidently will show that you're not just familiar with the basics, but that you’re ready to contribute to the Global Quality team.
✨Showcase Your Audit Experience
Prepare specific examples of your GVP auditing experience. Whether it’s leading audits or managing vendor relationships, having concrete stories ready will help demonstrate your expertise and how you can add value to their audit strategy.
✨Communicate Clearly
Since excellent written and verbal communication skills are essential for this role, practice articulating your thoughts clearly. You might be asked to present QA findings, so being concise and confident in your delivery is key.
✨Be Ready for Team Dynamics
This role involves collaboration with various teams, so think about how you’ve successfully worked in a team environment before. Be prepared to discuss how you handle different personalities and drive projects forward together.
