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For Companies At a Glance
- Tasks: Lead the development of the Pharmaceutical Quality System and ensure compliance with regulations.
- Company: Join a top-tier Pharmaceutical CDMO known for its exceptional growth and innovation.
- Benefits: Enjoy a full-time role with opportunities for training and career advancement.
- Why this job: Make a real impact in quality assurance while collaborating with diverse teams in a dynamic environment.
- Qualifications: Experience in QA within GMP settings and a relevant scientific degree are essential.
- Other info: Ideal for those passionate about pharmaceutical quality and eager to mentor others.
The predicted salary is between 42000 - 84000 £ per year.
Overview
Cure Talent is thrilled to partner with a leading Pharmaceutical CDMO who, due to their exceptional continued growth, have an exciting opportunity for a Senior Quality Associate to join their team.
In this role, you will take a lead in maintaining and developing the Pharmaceutical Quality System across UK and Ireland operations. You will provide specialist QA support across the full range of Quality Systems, including deviations, CAPA, change control, validation, supplier audits, and document control. You’ll also play a key role in hosting audits, training QA Officers, and supporting cross-functional teams to ensure operational compliance with GMP and GDP regulations.
Responsibilities
- Maintain and develop the company’s global PQS in line with current regulations and internal standards
- Oversee core PQS elements including change controls, CAPAs, deviations, complaints, document control, and risk management
- Provide QA support for validation, environmental monitoring, and technical documentation
- Review and approve batch records, QC test data, and finished product specifications
- Support and host internal, supplier, and regulatory audits
- Mentor and train QA Officers, delivering internal training on GMP and GDP requirements
- Collaborate with production and technical teams to ensure compliance across manufacturing, storage, and distribution
- Contribute to management reviews and present KPIs on Quality System performance
What you will need / Qualifications
- Proven experience in QA within a GMP-regulated pharmaceutical environment
- Strong knowledge of PQS management, including quality systems such as CAPA, change control, and deviations
- Experience supporting audits, document control, and product quality reviews
- Excellent team leadership, communication, and problem-solving skills
- A scientific degree (e.g. Chemistry, Pharmaceutical Sciences) or equivalent relevant experience
- Experience working with sterile and non-sterile products highly desirable
- Internal or Lead Auditor qualification preferred
Seniority level
- Mid-Senior level
Employment type
- Full-time
Industries
- Pharmaceutical Manufacturing
Get notified about this and similar Quality Assurance roles in the UK; refer a friend to increase your hiring chances.
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Senior Quality Associate employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Associate
✨Tip Number 1
Familiarise yourself with the latest GMP and GDP regulations. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to maintaining high-quality standards in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the pharmaceutical quality assurance field. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities at companies like us.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed CAPAs, change controls, and audits in your previous roles. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your leadership skills by highlighting any mentoring or training experiences you've had. As a Senior Quality Associate, you'll be expected to guide others, so demonstrating this capability will be crucial.
We think you need these skills to ace Senior Quality Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in QA within a GMP-regulated environment. Emphasise your knowledge of PQS management and any relevant qualifications, such as your scientific degree or auditor qualifications.
Craft a Compelling Cover Letter: In your cover letter, explain why you are passionate about quality assurance in the pharmaceutical industry. Mention specific experiences that demonstrate your ability to manage quality systems and support audits, as well as your leadership skills.
Showcase Relevant Experience: When detailing your work history, focus on your achievements related to CAPA, change control, and document control. Use metrics where possible to illustrate your impact, such as improvements in compliance rates or successful audit outcomes.
Prepare for Potential Questions: Anticipate questions related to your experience with GMP and GDP regulations, as well as your approach to mentoring and training others. Be ready to discuss how you've contributed to maintaining compliance in previous roles.
How to prepare for a job interview at Cure Talent
✨Showcase Your QA Expertise
Make sure to highlight your experience in Quality Assurance, especially within a GMP-regulated environment. Be prepared to discuss specific examples of how you've managed quality systems like CAPA and change control.
✨Prepare for Technical Questions
Expect questions related to the Pharmaceutical Quality System and be ready to explain your understanding of key elements such as document control and risk management. Brush up on relevant regulations to demonstrate your knowledge.
✨Demonstrate Leadership Skills
Since this role involves mentoring and training QA Officers, be ready to share your leadership experiences. Discuss how you've successfully led teams or projects in the past, focusing on communication and problem-solving.
✨Engage with Cross-Functional Teams
The role requires collaboration with various teams, so prepare to discuss how you've worked with production and technical teams in the past. Highlight any successful initiatives that improved compliance or operational efficiency.
