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- Tasks: Ensure high-quality pharmaceutical products through oversight and collaboration with external manufacturers.
- Company: Innovative BioPharma Company focused on quality and compliance.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Join a dynamic team making a real impact in the pharmaceutical industry.
- Qualifications: Bachelor's degree in a scientific field and 5 years of QA experience.
- Other info: Opportunity to travel and engage in continuous improvement initiatives.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Overview: This role provides Quality Assurance (QA) oversight for externally manufactured pharmaceutical products. The position ensures that commercial bulk and finished products are manufactured, tested, released, and distributed in full compliance with cGMP and global regulatory requirements. A key focus is managing and influencing external contract manufacturers while maintaining high-quality standards. Occasional travel may be required.
Key Responsibilities:
- Vendor & Product Quality Oversight: Serve as the primary QA contact for assigned products within global and international quality operations. Build and maintain strong working relationships with contract manufacturing sites. Lead quality‑related discussions with external partners, including topics such as deviations, OOS results, complaints, change controls, documentation, and processes. Drive continuous improvement initiatives and ensure timely completion of investigations, CAPAs, and quality actions.
- Documentation & Compliance: Review and approve master batch records and executed batch records for GMP and regulatory compliance. Oversee and manage change controls, including initiation, QA assessment, tracking, and escalation. Support and approve complaint investigations associated with external vendors. Review and negotiate contractor documentation such as validation protocols/reports, deviation reports, and OOS investigations. Lead or contribute to Annual Product Quality Reviews.
- Quality Systems & Audits: Draft, review, and negotiate Quality Agreements with external contractors. Participate in internal self‑inspections and external audits of CMOs and distributors. Maintain QA documentation, logs, and databases. Support regulatory inspections (e.g., FDA, EMA). Contribute to the development and maintenance of Pharmaceutical Quality Systems, SOPs, policies, and standards.
Required Skills & Competencies: Strong knowledge of global cGMP/GDP regulations (US, EU, international). Ability to balance business needs with robust scientific and quality decision‑making. Excellent analytical and problem‑solving skills. Strong relationship‑building skills to influence both internal and external stakeholders. Effective communication, organisational, and project‑management abilities. Proficiency with standard computer applications.
Qualifications & Experience: Bachelor's degree (or equivalent) in a scientific discipline. 5 years of QA experience within the pharmaceutical industry. Solid technical understanding of pharmaceutical manufacturing, QC, QA, and regulatory environments. Experience supporting FDA/EMA inspections. Proven experience working with external manufacturers or overseeing contract manufacturing operations.
Senior Quality Assurance Specialist in London employer: HAYS Specialist Recruitment
Contact Detail:
HAYS Specialist Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Specialist in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who work in QA or with contract manufacturers. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of cGMP and global regulations. We want you to showcase your expertise and how it aligns with the company's needs. Practice common QA scenarios and be ready to discuss your problem-solving skills!
✨Tip Number 3
Don’t forget to follow up after interviews! A quick thank-you email can keep you fresh in their minds. Mention something specific from your conversation to show you were engaged and are genuinely interested in the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to connect directly with us. Let’s get you that Senior QA Specialist role!
We think you need these skills to ace Senior Quality Assurance Specialist in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior QA Specialist role. Highlight your experience with cGMP regulations and any relevant QA projects you've led. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in the pharmaceutical industry. Share specific examples of how you've influenced external partners or improved processes.
Showcase Your Problem-Solving Skills: In your application, don't forget to mention your analytical and problem-solving abilities. We love candidates who can tackle challenges head-on, so share some stories that demonstrate your skills in action!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at HAYS Specialist Recruitment
✨Know Your Regulations
Make sure you brush up on your knowledge of global cGMP and GDP regulations. Being able to discuss these confidently will show that you understand the industry's standards and can navigate compliance issues effectively.
✨Build Relationships
Since this role involves managing external contract manufacturers, think about how you can demonstrate your relationship-building skills. Prepare examples of how you've successfully influenced stakeholders in previous roles, as this will be key in your discussions.
✨Showcase Problem-Solving Skills
Be ready to talk about specific challenges you've faced in QA and how you resolved them. Highlight your analytical skills and provide concrete examples of investigations or CAPAs you've led, as this will illustrate your ability to drive continuous improvement.
✨Prepare for Audits
Since you'll be participating in audits and inspections, it’s a good idea to prepare for questions around your experience with FDA and EMA inspections. Share any relevant experiences and how you contributed to successful outcomes during these processes.
