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For Companies At a Glance
- Tasks: Lead and manage audits focused on Computer System Validation in the pharma industry.
- Company: Join a well-known pharma company with a strong reputation in global quality management.
- Benefits: Enjoy a competitive salary, car allowance, bonus, and generous benefits package.
- Why this job: Be part of a dynamic team driving quality improvements and regulatory compliance in healthcare.
- Qualifications: Degree in natural science or equivalent experience; expertise in GxP and CSV audits required.
- Other info: Collaborate closely with senior leadership and contribute to impactful quality initiatives.
The predicted salary is between 54000 - 84000 £ per year.
My client a well know pharma company is seeking an experienced Senior Manager, Global Quality Management to join their Global Quality Management team.
Based in Berkshire my client offers a generous package including a competitive salary, car allowance and bonus.
You must have worked within the pharmaceutical industry with experience in GxP related CSV audits and inspections
Role
The main task is to manage and perform audits with focus on Computer System Validation (CSV) audits.
Additional tasks are to support the continuous improvement of the Quality System, the inspection management, the regulatory intelligence activities, the SOP and WP management, and the project liaison activities
Working in close collaboration with the Head of Global Quality Management of GCP, CSV & GVP, Senior Director Global Quality Management and the CSV Audit Lead:
Key Accountabilities
- Support the development, implementation, continuous improvement and documentation of Companies’ Quality System
- Support inspections
- Support the audit process
- Support Regulatory Intelligence
- Support the management of the global, regional and local Standard Operating Procedures (SOPs) and Working Practices (WPs)
- Support the validated state of computerised systems
- Provide advice and act as project liaison
Skills & Experience
- Degree in natural science or equivalent business experience
- Several years of Information Technology (IT) industry/pharmaceutical industry/medical devices industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance and Clinical Development and Computerised System Validation and Data Integrity
- Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Computerised System Validation, Data Integrity, Manufacturing, Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance
- Experience as a Lead Auditor on internal audits and external vendor audits.
- Experienced in GxP related CSV audits and inspections
- Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or development
- Understanding of computer hardware and network/infrastructure requirements
Senior Manager, Global Quality employer: Parkside Recruitment
Contact Detail:
Parkside Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Global Quality
✨Tip Number 1
Make sure to highlight your experience with GxP related CSV audits and inspections during networking opportunities. Connect with professionals in the pharmaceutical industry on platforms like LinkedIn, and engage in discussions about quality management practices.
✨Tip Number 2
Stay updated on the latest regulations and guidance documents related to Computerised System Validation and Data Integrity. This knowledge will not only help you in interviews but also demonstrate your commitment to continuous improvement in quality management.
✨Tip Number 3
Consider joining relevant professional organizations or attending industry conferences. These events are great for networking and can provide insights into best practices in Quality Assurance that you can discuss during your application process.
✨Tip Number 4
Prepare to discuss specific examples of how you've supported the development and implementation of Quality Systems in your previous roles. Being able to articulate your contributions will set you apart from other candidates.
We think you need these skills to ace Senior Manager, Global Quality
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in the pharmaceutical industry, particularly focusing on GxP related CSV audits and inspections. Use specific examples that demonstrate your expertise in Quality Assurance and Computer System Validation.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality management in the pharmaceutical sector. Mention how your background aligns with the key accountabilities of the role and your ability to support the development and improvement of Quality Systems.
Highlight Relevant Skills: Clearly outline your skills and experiences that are relevant to the position, such as your knowledge of regulations, experience as a Lead Auditor, and understanding of computerized systems in a GxP environment. This will help you stand out.
Proofread Your Application: Before submitting your application, carefully proofread all documents to ensure there are no errors. A polished application reflects your attention to detail, which is crucial in quality management roles.
How to prepare for a job interview at Parkside Recruitment
✨Showcase Your GxP Expertise
Make sure to highlight your experience with GxP related CSV audits and inspections. Be prepared to discuss specific examples where you successfully managed audits or improved quality systems in your previous roles.
✨Demonstrate Continuous Improvement Mindset
Discuss how you've contributed to the continuous improvement of quality systems in past positions. Share concrete examples of initiatives you've led or participated in that enhanced compliance or efficiency.
✨Familiarize Yourself with Relevant Regulations
Brush up on the latest regulations and guidance documents related to Computerised System Validation, Data Integrity, and Quality Assurance. Being able to reference these during your interview will show your depth of knowledge and commitment to the field.
✨Prepare for Behavioral Questions
Expect questions that assess your leadership and problem-solving skills. Prepare to share experiences where you acted as a project liaison or led audit teams, focusing on the outcomes and lessons learned from those situations.
