At a Glance
- Tasks: Lead quality assurance operations and ensure compliance in a dynamic laboratory environment.
- Company: Join a leading CRO in Cwmbran with a commitment to quality and integrity.
- Benefits: Competitive salary, career development opportunities, and a collaborative work culture.
- Other info: Opportunity to mentor and develop a team while enhancing quality systems.
- Why this job: Make a real impact by driving quality standards and continuous improvement.
- Qualifications: Significant QA experience in GMP-regulated environments and strong leadership skills.
The predicted salary is between 40000 - 50000 £ per year.
A leading CRO is looking for a Quality Manager to join its Cwmbran team, taking ownership of day-to-day Quality Assurance operations and ensuring both GMP and non-GMP activities meet the highest standards of compliance, integrity, and client commitment.
In this pivotal role, you'll provide hands-on QA leadership across the full spectrum of quality system activities - from laboratory oversight and supplier audits to inspection readiness and documentation review. You'll be expected to apply pragmatic, risk-based judgement suited to a dynamic contract laboratory environment where regulated and non-regulated activities coexist.
As a senior quality practitioner and people manager, you'll guide operational teams, coach staff on GMP and non-GMP expectations, and step in to deputise for the Head of Quality when required. This is a role for someone who thrives on responsibility, collaboration, and driving a culture of compliance and continuous improvement.
Key Responsibilities- Provide routine QA oversight of GMP and non-GMP laboratory activities
- Maintain and improve the Pharmaceutical Quality System (PQS), including deviations, CAPAs, change controls, and investigations
- Arrange, host, and respond to client audits and regulatory inspections
- Lead, perform, and report on internal audits in line with the site audit programme
- Conduct supplier audits, oversee supplier qualification, and maintain the Approved Supplier List
- Apply data integrity and CSV principles across GxP systems
- Support or lead implementation of electronic Quality Management Systems (eQMS)
- Line-manage 2 QA direct reports and mentor up to 4 indirect reports
- Identify training needs, coach staff, and promote a strong quality culture
- Drive continuous improvement initiatives across QA processes and systems
- Significant QA experience within a GMP-regulated environment
- Experience in a contract laboratory or service-based organisation conducting GMP and non-GMP activities
- Demonstrable experience conducting internal and supplier audits
- Proven track record supporting and hosting client and regulatory inspections
- Strong working knowledge of EU GMP, FDA CFRs, Annex 11, and ICH Q8-Q10
- Sound understanding of data integrity and CSV principles
- Approachable, credible, and collaborative leadership style
- Confident communicator with internal stakeholders, clients, and regulators
- Practical, solution-focused, and calm under inspection conditions
- Experience implementing or enhancing electronic Quality Management Systems (eQMS)
- QMS Lead Auditor qualification
- Certified training within GxP
Quality Manager in Cwmbran employer: Smart4Sciences
As a leading CRO located in Cwmbran, we pride ourselves on fostering a collaborative and dynamic work environment where quality assurance is at the forefront of our operations. Our commitment to employee growth is evident through comprehensive training programmes and mentorship opportunities, ensuring that our team members thrive in their roles while contributing to a culture of compliance and continuous improvement. With a focus on integrity and client commitment, we offer a rewarding career path for those passionate about making a meaningful impact in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Manager in Cwmbran
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Smart4Sciences. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Smart4Sciences.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Smart4Sciences. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Smart4Sciences is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Quality Manager in Cwmbran
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Smart4Sciences!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Smart4Sciences that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Smart4Sciences!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Smart4Sciences, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Smart4Sciences
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Smart4Sciences that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Smart4Sciences’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
