At a Glance
- Tasks: Lead the QA team to ensure compliance with GMP standards in biologics manufacturing.
- Company: Pioneering company in the Cell & Gene Therapy sector.
- Benefits: Competitive salary, bonus, pension, and opportunities for professional growth.
- Other info: Join a dynamic team and make a real impact in a cutting-edge facility.
- Why this job: Shape the future of innovative therapies while developing your leadership skills.
- Qualifications: Strong QA experience in GMP systems, preferably in biologics or vaccines.
The predicted salary is between 36000 - 60000 £ per year.
Are you an experienced Quality Assurance professional looking to step up into management? Do you have a strong knowledge of GMP operations and the manufacture of biologics, vaccines, or advanced therapies? Are you ready for an exciting new challenge? A pioneering company in the Cell & Gene Therapy sector is seeking a QA Lead to join their Quality Department. Reporting to the Head of Quality Assurance, the QA Lead will ensure that the facility meets the standards and expectations of key stakeholders, regulatory authorities, and collaborators.
This position provides a unique opportunity to develop your leadership skills and contribute to obtaining a manufacturing license for a cutting-edge sterile vaccine manufacturing facility. A competitive salary and benefits package, including a bonus and pension, are on offer.
Key Responsibilities- Provide leadership to the QA Operations team, ensuring effective management of the Quality Management System (QMS) and supporting ongoing design, commissioning, and validation activities.
- Offer support for new product introduction (NPI), batch-related documentation review, and investigation of failures, ensuring appropriate actions are identified, reviewed, and implemented.
- Lead efforts to establish governance processes ensuring the manufacture of products conforming to GMP regulations and expectations of customers or collaborators.
- Actively participate in audits and inspections, interacting directly with inspectors.
- Provide subject matter expertise for QA across the facility and facilitate GMP issue escalation through the QMS.
- Support the execution of the GMP internal audit program, identifying, reviewing, and implementing corrective actions.
- Assist with recruitment and development of a high-performing quality team and conduct performance reviews for team members.
- Strong QA experience working with GMP quality systems in a Phase III or commercial pharmaceutical facility, particularly in biologics, vaccines, or cell & gene therapies.
- BSc, MSc, or similar in a life science discipline.
- Experience working in smaller or start-up organizations, with a pragmatic attitude and strong problem-solving skills.
- Significant experience in biologics, particularly cellular and/or gene therapies.
- Previous managerial experience is desirable.
- Experience building and establishing GMP quality systems in a Phase III or commercial manufacturing facility.
- Familiarity with regulatory authorities and the global standards for GMP manufacture, including EU, MHRA, FDA, and ISO 9001.
- Strong interpersonal, communication (oral and written), and influencing skills, with the ability to engage constructively with colleagues at all levels across departments.
This role offers a unique opportunity to shape and influence the quality operations of a growing organization at the forefront of innovative therapies.
Quality Assurance Lead - GMP Biologics in Cambridge employer: SLS Services Limited
Join a pioneering deep-tech company in Glasgow that is revolutionising chemical discovery through the integration of AI, robotics, and an extensive database of chemical programs. With a strong focus on innovation and impact, this employer offers a collaborative work culture, exceptional growth opportunities, and the chance to lead cutting-edge projects that directly influence the future of drug discovery. Experience a unique environment where your expertise in computational chemistry can thrive, supported by state-of-the-art facilities and a commitment to rapid, meaningful advancements in the field.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Lead - GMP Biologics in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their products and recent developments in the cell and gene therapy sector. We want you to walk in feeling confident and ready to impress with your knowledge and enthusiasm!
✨Tip Number 3
Practice your answers to common interview questions, especially those related to quality assurance and GMP regulations. We suggest doing mock interviews with friends or mentors to refine your responses and get comfortable with the format.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in showing your appreciation and keeping you top of mind. And remember, check out our website for more opportunities that match your skills!
We think you need these skills to ace Quality Assurance Lead - GMP Biologics in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Assurance Lead role. Highlight your experience with GMP operations and any relevant projects in biologics or vaccines. We want to see how your background aligns with 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 excited about this opportunity and how your skills can contribute to our team. Be sure to mention your leadership experience and familiarity with regulatory standards.
Showcase Your Problem-Solving Skills:In your application, don’t forget to highlight specific examples where you've tackled challenges in QA. We love seeing how you approach problem-solving, especially in a fast-paced environment like ours!
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 innovative team!
How to prepare for a job interview at SLS Services Limited
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of GMP operations, especially in relation to biologics and vaccines. Be prepared to discuss specific examples from your past experience that demonstrate your understanding of GMP regulations and how you've applied them in a real-world setting.
✨Showcase Your Leadership Skills
As a QA Lead, you'll need to demonstrate your leadership capabilities. Think of instances where you've successfully managed a team or led a project. Be ready to share how you motivated your team, resolved conflicts, and ensured high-quality outcomes.
✨Prepare for Audits and Inspections
Since this role involves participating in audits and inspections, it’s crucial to be familiar with the audit process. Prepare by reviewing common audit questions and think about how you would handle challenging situations during an inspection. Highlight any previous experiences you have in this area.
✨Engage with the Interviewers
Interviews are a two-way street! Prepare thoughtful questions about the company’s quality management systems and their approach to new product introductions. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
