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- Tasks: Lead quality assurance processes and ensure compliance in a dynamic pharmaceutical environment.
- Company: Join an award-winning CDMO in Greater Manchester, specialising in product development and trials.
- Benefits: Competitive salary, opportunities for growth, and a chance to impact healthcare positively.
- Why this job: Be part of a rapidly growing team that values innovation and quality in life sciences.
- Qualifications: Degree in life sciences and extensive QA leadership experience in Pharma/CMO required.
- Other info: Work closely with regulatory bodies and lead critical inspections and audits.
The predicted salary is between 38000 - 45000 £ per year.
Job Title: Senior QA Specialist Salary: £38,000 – £45,000 Location: Greater Manchester SRG is currently working exclusively with a highly successful & award winning, CDMO based in Greater Manchester. Growing rapidly, the business specialises in taking products from discovery, all the way through early-stage trials, and to approval. They are now looking for an experienced QA Manager to join them and take ownership over the QMS. Typical responsibilities/accountabilities: Work with Qualified Person to enable the efficient evaluation and release of IMP to clinical studies on clients\’ behalf. To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc. Take the lead on regulatory inspections and client audits, taking accountability (with the Site Leadership Team) for the approval and maintenance of the site MHRA MIA (IMP) licence. To ensure compliance with regulatory filings and regulatory agency reporting, and the implementation of compliance site initiatives and procedures. To oversee compliance during the design, construction, start-up, validation, and retirement of equipment, process, utilities, facilities, computer systems, etc. Essential Requirements: Degree or equivalent qualification in a life science or similar subject Extensive recent experience of QA leadership in a Pharma/CMO company. Proven track record in supporting QP release. Excellent knowledge of global regulations, and experience of dealing with MHRA. Good communication skills internally and in a client facing role. Experience of early-phase product development and IMP manufacturing would be highly advantageousJob Title: Senior QA Specialist Salary: £38,000 – £45,000 Location: Greater Manchester SRG is currently working exclusively with a highly successful & award winning, CDMO based in Greater Manchester. Growing rapidly, the business specialises in taking products from discovery, all the way through early-stage trials, and to approval. They are now looking for an experienced QA Manager to join them and take ownership over the QMS. Typical responsibilities/accountabilities: Work with Qualified Person to enable the efficient evaluation and release of IMP to clinical studies on clients\’ behalf. To provide support and leadership on a range of activities including but not limited to: non-conformance management, including CAPA, events, root cause analysis, continuous improvement, key supplier issues, complaint investigations etc. Take the lead on regulatory inspections and client audits, taking accountability (with the Site Leadership Team) for the approval and maintenance of the site MHRA MIA (IMP) licence. To ensure compliance with regulatory filings and regulatory agency reporting, and the implementation of compliance site initiatives and procedures. To oversee compliance during the design, construction, start-up, validation, and retirement of equipment, process, utilities, facilities, computer systems, etc. Essential Requirements: Degree or equivalent qualification in a life science or similar subject Extensive recent experience of QA leadership in a Pharma/CMO company. Proven track record in supporting QP release. Excellent knowledge of global regulations, and experience of dealing with MHRA. Good communication skills internally and in a client facing role. Experience of early-phase product development and IMP manufacturing would be highly advantageousCarbon60, Lorien & SRG – The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy
Senior QA Specialist employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior QA Specialist
✨Tip Number 1
Familiarise yourself with the specific regulations and guidelines set by the MHRA, as this role requires a strong understanding of compliance. Being able to discuss these regulations confidently during your interview will demonstrate your expertise and readiness for the position.
✨Tip Number 2
Highlight your experience in non-conformance management and CAPA processes. Prepare examples from your previous roles where you successfully led investigations or implemented improvements, as this will show your capability to handle similar challenges at StudySmarter.
✨Tip Number 3
Network with professionals in the QA field, especially those who have worked in Pharma or CMO environments. Engaging with industry peers can provide insights into the company culture and expectations, which can be beneficial during your interview.
✨Tip Number 4
Prepare to discuss your leadership style and how you manage teams in high-pressure situations. This role involves taking ownership of the QMS, so showcasing your ability to lead effectively will be crucial in making a strong impression.
We think you need these skills to ace Senior QA Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive QA leadership experience in Pharma/CMO companies. Emphasise your proven track record in supporting QP release and your knowledge of global regulations.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the role's responsibilities. Mention specific experiences that relate to non-conformance management, regulatory inspections, and compliance initiatives.
Highlight Relevant Qualifications: Clearly state your degree or equivalent qualification in a life science or similar subject. If you have any additional certifications related to QA or regulatory affairs, be sure to include those as well.
Showcase Communication Skills: Since good communication skills are essential for this role, provide examples in your application where you've successfully communicated with clients or led teams. This will demonstrate your ability to thrive in both internal and client-facing situations.
How to prepare for a job interview at SRG
✨Showcase Your QA Expertise
Make sure to highlight your extensive experience in QA leadership, especially within Pharma or CMO environments. Be prepared to discuss specific examples of how you've successfully managed non-conformance issues and CAPA processes.
✨Demonstrate Regulatory Knowledge
Familiarise yourself with global regulations and the specifics of MHRA compliance. During the interview, be ready to explain how you've navigated regulatory inspections and audits in the past.
✨Communicate Effectively
Since good communication skills are essential for this role, practice articulating your thoughts clearly. Prepare to discuss how you've effectively communicated with both internal teams and clients in previous positions.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving abilities. Think about challenges you've faced in early-phase product development and how you ensured compliance during various stages of the process.
