At a Glance
- Tasks: Lead quality strategy and ensure compliance in groundbreaking therapies.
- Company: Advent Bioservices, a leader in advanced therapy medicinal products.
- Benefits: Attractive salary, comprehensive benefits, and opportunities for professional growth.
- Other info: Dynamic role with leadership opportunities in a growing organisation.
- Why this job: Join a pioneering team making a real difference in healthcare.
- Qualifications: MSc in relevant field and significant GMP quality management experience.
The predicted salary is between 70000 - 90000 £ per year.
Advent Bioservices is a Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life‑threatening diseases are treated using advanced therapy medicinal products.
The Head of Quality will work with the President and Senior Managers to ensure the efficient and effective day-to-day running of the QA, Validation and QC department, ensuring the design elements and the implementation of the PQS meet the relevant regulatory compliance requirements, managing all activities supporting pharmaceutical product manufacture, testing and certification, as well as being responsible for approving and releasing unlicensed medicine manufactured under Advent's MHRA Specials license.
Key responsibilities will include:
- Lead and implement the company’s quality strategy in line with business goals and GMP/UK regulatory requirements
- Maintain and continuously improve a robust Quality Management System (QMS)
- Champion a culture of quality, compliance and patient safety across the organisation
- Provide quality leadership across commercial, clinical and development stage cell therapy products
- Act as the primary quality regulatory inspections and client audits
Quality and Compliance
- Oversee and enhance the eQMS
- Monitor QMS performance and drive continuous improvement initiatives
- Ensure ongoing regulatory compliance and maintenance of licences
- Lead internal GMP audits, supplier audits and regulatory inspections
- Manage investigations, including deviations, complaints and out of specification results
- Develop and maintain SOP’s, QC protocols and quality documentations
- Analyse and present quality and operational performance data
Technical and QC Oversight
- Oversee QC operations for ATMP’s including testing, validation and release activities
- Approve raw materials, packing components and finished products
- Manage environmental monitoring and microbiological control programmes
- Ensure validation of analytical methods, equipment and laboratory systems
- Oversee stability programmes, sampling plans and contract testing
- Provide QC guidance and support to manufacturing teams
Validation and Equipment
- Ensure validation strategies for facilities, utilities and equipment comply with regulatory standards
- Support validation activities across production and QC
- Oversee maintenance, qualification and compliance of laboratory environments and equipment
Leadership and Management
- Lead QA, QC and Validation teams
- Drive companywide training and awareness of quality systems
- Support senior leadership and business development activities
- Provide strategic oversight across quality and operational functions
Regulatory and External Engagement
- Act as main contact for regulatory authorities, clients and external partners
- Support Qualified Person (QP) activities
- Ensure compliance with MHRA, GMP, ATMP and HTA requirements
The successful candidate will have the following experience/qualifications:
- MSc in relevant scientific discipline (Pharmaceutical Sciences, Biotechnology, Biochemistry) or equivalent.
- Significant experience working as a senior quality manager within a GMP Quality department in the manufacture of cell and/or gene therapy products
- Experience of liaison with regulatory authorities (HTA and MHRA)
- Experience in establishing and maintaining a Contamination Control Strategy
- Experience of validation of facilities and equipment
- Demonstrated knowledge of Quality Control, Quality Assurance, validation, GMP, MHRA Regulatory Compliance and testing and packaging of ATMPs
- Experience of Regulatory Compliance and testing and packaging of ATMPs
- Ability to interpret complex data and present key findings
- Good documentation practice and QC reporting
- Experience of microbiology and analytical methods in cell therapy
This is a fantastic opportunity to join a growing organisation. We offer an attractive base salary and benefits package.
Head of Quality employer: Advent Bioservices
Advent Bioservices is an exceptional employer, offering a dynamic work environment at the forefront of revolutionary medicine. With a strong commitment to quality and compliance, employees benefit from a culture that champions patient safety and continuous improvement, alongside opportunities for professional growth in the rapidly evolving field of advanced therapy medicinal products. Located in a vibrant area, Advent provides a competitive salary and comprehensive benefits package, making it an ideal place for those seeking meaningful and rewarding careers in the pharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Quality
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Advent Bioservices. 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 Advent Bioservices.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Advent Bioservices. 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 Advent Bioservices is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Head of Quality
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 Advent Bioservices!
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 Advent Bioservices 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 Advent Bioservices!
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 Advent Bioservices, 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 Advent Bioservices
✨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 Advent Bioservices 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 Advent Bioservices’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.
