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- Tasks: Manage Quality Management System processes and ensure GxP compliance.
- Company: Join IPSEN, a dynamic and innovative leader in the pharmaceutical industry.
- Benefits: Gain opportunities for professional growth and become a qualified auditor.
- Why this job: Be part of a high-performing team focused on quality and compliance.
- Qualifications: Degree in life sciences or equivalent experience; previous quality role in pharma required.
- Other info: IPSEN values diversity and encourages all individuals to apply.
The predicted salary is between 43200 - 72000 £ per year.
As a Senior Quality Specialist, you will be an integral part of the Quality function within the UK & Ireland Commercial affiliate. You will work closely with and support the Senior Quality Manager/Responsible Person to manage all aspects of the Quality Management System (QMS), ensuring that your covered regions are GxP compliant and inspection ready.
If you’re passionate about quality, have a curious and proactive mind set and are ready to take on new challenges with a high performing team and department, we would love to hear from you!
Responsibilities:
Take ownership and provide support on QMS processes (Deviations, CAPA & Change Controls) including Root Cause Analysis, Risk Assessment, Action completion, and timely closure of records.
Act as a Training Specialist – accountable for the UKIE Training Matrix, manage training within iLearn, conduct monthly Quality Inductions, and provide general business support.
Act as an SME for Quality Risk Management – chair Risk Management Committee Meetings, ensure all identified GxP risks are captured and progressed, complete trending, reporting, and measure process effectiveness.
Manage GxP Change Controls including oversight, progression of records, trending, reporting, and measuring process effectiveness.
Log and manage Temperature Excursions.
Manage controlled documentation including the completion of gap analyses vs global document updates.
Lead the completion of Product Quality Review.
Responsible for the management of the Quality functions section of the RQ SharePoint.
Provide SME insight and content for Management Review activities.
Complete checks to confirm that products imported into Great Britain and requiring QP certification are locally released.
Engage with local and global supply chain colleagues to maintain awareness of planned shipments and product types.
Receive, log, and manage Product Quality Complaints including engagement with manufacturing sites on investigation reports.
Complete weekly reconciliation reports.
Complete trending reports on complaint types and measure process effectiveness.
Support the Senior Quality Manager in compiling the annual audit risk assessment and schedule.
Responsible for the annual mock recall.
Complete Internal and External Vendor Audits. While providing support during Ipsen local and global inspections and audits.
Complete activities conducted by the RQ Officer in times of absence:
Administrative activities associated with the electronic document system (Easidoc).
Creation & Allocation of training in the electronic training system (iLearn).
Generation of KPIs and metrics.
Complete delegated activities for the Responsible Person (UKIE) in times of absence.
Additional project work as defined in annual objectives & development plan.
We are excited to announce an opening for a Senior Quality Specialist role within our dynamic, innovative, and collaborative team. This position is perfect for someone with extensive experience in quality who is eager to contribute to a high-visibility role. The successful candidate will have the opportunity to become a qualified auditor, Responsible Person and Responsible Person for import if they are not already at this level. Proven experience in quality (especially GDP), strong regulatory knowledge, and excellent communication skills are essential for this role., Educated to Degree level (life sciences) or equal experience.
Previous experience within a Quality role.
Previous experience within the pharmaceutical industry
Detailed knowledge of EU Good Distribution Practice and MHRA/HPRA requirements.
Experience of participating in both internal GxP audits and regulatory inspections.
Knowledge and training within GxP.
Experience and advanced knowledge of Microsoft Office.
Excellent verbal, written, analytical, and interpersonal skills.
Self-motivated, organised, and able to problem solve.
Preferred requirements:
Experience as a Responsible Person for Import (RPi).
Quality Management System Lead Auditor or Pharmaceutical GMP Lead Auditor Qualification
Membership of an acceptable professional body.
IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
Senior Quality Specialist employer: Ipsen
Contact Detail:
Ipsen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Specialist
✨Tip Number 1
Familiarize yourself with the specific GxP regulations and guidelines relevant to the UK and Ireland. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality management.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience in quality roles. Engaging with them can provide insights into the company culture and expectations, which can be beneficial during your application process.
✨Tip Number 3
Prepare to discuss your experience with Quality Management Systems in detail. Be ready to share specific examples of how you've managed deviations, CAPA, and change controls in previous roles, as this will showcase your expertise.
✨Tip Number 4
Stay updated on the latest trends and challenges in quality management within the pharmaceutical sector. This knowledge will help you engage in meaningful conversations during interviews and show that you're proactive about your professional development.
We think you need these skills to ace Senior Quality Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Quality Specialist position. Tailor your application to highlight your relevant experience in quality management systems and GxP compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasize your previous experience in quality roles, particularly within the pharmaceutical industry. Mention specific examples of your work with QMS processes, audits, and regulatory inspections.
Showcase Your Skills: Demonstrate your strong communication skills and problem-solving abilities in your application. Provide examples of how you've effectively managed training, conducted root cause analysis, or led risk management meetings.
Tailor Your Cover Letter: Craft a personalized cover letter that reflects your passion for quality and your proactive mindset. Address how you can contribute to the high-performing team at IPSEN and mention any relevant qualifications or memberships.
How to prepare for a job interview at Ipsen
✨Show Your Passion for Quality
Make sure to express your enthusiasm for quality management during the interview. Share specific examples of how you've contributed to quality improvements in your previous roles, and demonstrate your proactive mindset.
✨Be Prepared to Discuss QMS Processes
Since the role involves managing QMS processes like Deviations, CAPA, and Change Controls, be ready to discuss your experience with these areas. Prepare to explain how you've handled Root Cause Analysis and Risk Assessment in past positions.
✨Highlight Your Regulatory Knowledge
Given the importance of GxP compliance, ensure you can articulate your understanding of EU Good Distribution Practice and MHRA/HPRA requirements. Be prepared to discuss any relevant audits or inspections you've participated in.
✨Demonstrate Strong Communication Skills
As this role requires excellent communication skills, practice articulating your thoughts clearly and concisely. Be ready to provide examples of how you've effectively communicated with cross-functional teams and managed training initiatives.
