At a Glance
- Tasks: Lead quality assurance for pharmaceutical products, ensuring compliance and safety.
- Company: Join a leading pharmaceutical client in London with a focus on innovation.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Collaborate with diverse teams and drive quality improvements across operations.
- Why this job: Be the final authority on product quality and patient safety in a dynamic environment.
- Qualifications: 10-15 years in pharma/biotech, with a relevant degree and GMP experience.
The predicted salary is between 80000 - 100000 £ per year.
Client: Pharmaceutical Client
Role: Qualified Person (QP) - Head of Quality
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 London employer: LanceSoft UK
As a leading pharmaceutical employer in London, we pride ourselves on fostering a collaborative and innovative work culture that prioritises employee growth and development. Our commitment to excellence is reflected in our comprehensive benefits package, which includes professional training opportunities, competitive salaries, and a supportive environment that encourages work-life balance. Join us to make a meaningful impact in the pharmaceutical industry while advancing your career in a dynamic and rewarding setting.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Quality Assurance in London
✨Get Involved in Campus Activities
Join pharmaceutical clubs or societies at your university. These often host events where you can meet professionals, learn about the industry, and even score internships with companies like LanceSoft UK. Plus, it's a great way to make connections that could help you land a job later.
✨Attend Industry Conferences and Job Fairs
Look out for job fairs and pharmaceutical conferences. These are gold mines for finding internships and getting to know potential employers. Make sure you turn up with your best elevator pitch ready to impress recruiters from companies like LanceSoft UK!
✨Leverage Your University Career Centre
Your university's career service is there to help you find internships and jobs. Make an appointment to chat about your goals, get help with your CV tailored for the pharmaceutical field, and tap into their network of employers looking for fresh talent like us!
✨Apply Directly Through Our Website
Don't forget to check out the LanceSoft UK website for our internship opportunities! We often post exclusive roles that might not be listed elsewhere, so applying directly could give you a head start over the competition.
We think you need these skills to ace Head of Quality Assurance in London
Some tips for your application 🫡
Show Off Your Academic Achievements:In the pharmaceutical industry, grades really matter, so don't shy away from showcasing your academic performance in your CV. If you've taken any relevant courses, like pharmacology or organic chemistry, make sure they’re front and centre. We love to see that commitment to your studies!
Highlight Relevant Projects and Lab Experience:If you’ve been involved in any lab work or projects during your studies, this is the time to shout about it! Describe your role, what skills you gained, and any technologies you worked with. It gives us a glimpse of your hands-on experience and your readiness for the field.
Craft a Personalised Cover Letter:Your cover letter is your chance to share your passion for the pharmaceutical industry. Be sure to include why you're excited about working at LanceSoft UK and how this role as a bachelor intern aligns with your career goals. Let your enthusiasm shine through!
Include Your Certifications:If you have any certifications relevant to pharmaceuticals, like Good Laboratory Practice (GLP) or safety training, make sure you list them in your application. It shows us that you’re not just academically prepared but also equipped with the right certifications to jump straight into the internship.
How to prepare for a job interview at LanceSoft UK
✨Know Your Pharma Basics
Make sure you’ve got a good grasp of the pharmaceutical industry and its key players. Brush up on any recent developments, especially those related to LanceSoft UK. They might throw a technical question your way, so understanding drug development processes could be a game changer!
✨Show Off Your Research Skills
As a bachelor student, they're likely looking for candidates who can prove they know how to gather and analyse data. Be prepared to discuss any relevant projects or coursework where you applied these skills, especially if they relate to the specific role at LanceSoft UK!
✨Get Comfortable with Regulatory Talk
It’s super important to understand the regulatory landscape of the pharma sector. Brush up on the basics of compliance and any relevant regulations, as you might face questions around how these can impact drug development. This shows that you’re not just book smart but practically aware too.
✨Highlight Your Passion for the Industry
During the interview, make sure to express why you want to jump into the pharmaceutical world. Share your enthusiasm about helping develop new treatments or improving patient outcomes. Being a bachelor candidate, your eagerness to learn could be your strongest asset, so let it shine!