At a Glance
- Tasks: Lead quality assurance for pharmaceutical products, ensuring compliance and safety.
- Company: Reputable pharmaceutical client based in London.
- Benefits: Competitive salary, career advancement, and a chance to impact patient safety.
- Other info: Join a dynamic team with opportunities for professional growth and development.
- Why this job: Be the final authority on product quality and make a difference in healthcare.
- Qualifications: Bachelor’s degree in relevant scientific field and 10-15 years of industry experience.
The predicted salary is between 80000 - 100000 £ per year.
Client: Pharmaceutical Client
Location: London, UK
Required:
- Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Microbiology, Engineering, or related scientific discipline.
- Minimum 10–15 years of pharmaceutical, biotechnology, or biologics manufacturing experience.
Description:
The Qualified Person (QP) is responsible for ensuring that medicinal products are manufactured, tested, stored, and distributed in compliance with applicable GMP regulations, marketing authorizations, regulatory commitments, and company quality standards. The QP serves as the final quality authority for batch certification and release decisions and provides strategic quality oversight across manufacturing, quality control, validation, engineering, supply chain, and regulatory functions. The position requires extensive knowledge of pharmaceutical manufacturing processes, quality systems, contamination control strategies, regulatory requirements, and risk management principles. The QP is expected to exercise independent judgment in evaluating product quality, patient safety, and regulatory compliance.
Key responsibilities:
- Perform final review and certification of clinical and commercial drug substance and drug product batches.
- Ensure all manufacturing, packaging, testing, and release activities are conducted in accordance with applicable GMP regulations and approved procedures.
- Review executed batch records, laboratory data, environmental monitoring results, deviations, investigations, CAPAs, change controls, and quality events prior to disposition decisions.
- Evaluate product quality impact and determine batch release, rejection, or additional assessment requirements.
- Maintain oversight of batch disposition activities and product release timelines.
- Provide quality oversight for deviations, CAPAs, change controls, risk assessments, complaints, and supplier quality activities.
- Provide quality oversight for upstream, downstream, fill-finish, packaging, warehousing, and distribution operations.
- Partner with Manufacturing, Quality Control, Validation, Engineering, MSAT, Supply Chain, Regulatory Affairs, and Client Quality teams.
Key requirements:
- Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Microbiology, Engineering, or related scientific discipline.
- Minimum 10–15 years of pharmaceutical, biotechnology, or biologics manufacturing experience.
- Extensive experience in GMP-regulated environments.
- Experience supporting sterile manufacturing, biologics, cell therapy, gene therapy, or advanced therapy medicinal products preferred.
- Demonstrated experience with product disposition and batch release activities.
- Experience leading complex investigations, CAPAs, and quality system improvements.
- Prior experience supporting regulatory inspections and customer audits.
- EU GMP Annex 16 FDA cGMP Regulations
- Quality Risk Management (ICH Q9)
- Pharmaceutical Quality Systems (ICH Q10)
Head of Quality Assurance in City of London employer: LanceSoft UK
As a leading pharmaceutical client based in London, we pride ourselves on fostering a dynamic work environment that prioritises quality and compliance. Our commitment to employee development is evident through continuous training opportunities and a collaborative culture that encourages innovation and excellence. Join us to make a meaningful impact in the pharmaceutical industry while enjoying the vibrant lifestyle that London has to offer.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Quality Assurance in City of London
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like LanceSoft UK. 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 LanceSoft UK.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like LanceSoft UK. 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 LanceSoft UK is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Head of Quality Assurance in City of London
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 LanceSoft UK!
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 LanceSoft UK 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 LanceSoft UK!
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 LanceSoft UK, 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 LanceSoft UK
✨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 LanceSoft UK 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 LanceSoft UK’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.
