At a Glance
- Tasks: Lead quality assurance for innovative tech in clinical trials and ensure compliance.
- Company: Join Novartis, a leader in reimagining medicine with a diverse and inclusive culture.
- Benefits: Competitive salary, performance bonuses, flexible working, and generous parental leave.
- Other info: Dynamic role with opportunities for growth and collaboration across global teams.
- Why this job: Make a real impact in healthcare by ensuring quality in cutting-edge technology.
- Qualifications: Experience in pharmaceutical development and knowledge of quality management systems required.
The predicted salary is between 91700 - 118703 £ per year.
This role is based in London, UK. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.
As Associate Director External Service Provider QA, you will have an excellent opportunity to work as a liaison with the Novartis clinical trial teams and Third Parties to provide expert QA support during the Third-Party due diligence, qualification and on-going governance and monitoring. The use of various types of technology (i.e., DHTs, Medical devices, AI) continues to evolve for use in clinical trials. As such, the approach to qualification and oversight continues to evolve and change, requiring adaptive approaches and specialized skills.
Key Responsibilities
- QA support for technology-enabled (DHT, SaMD, SaaS) Third Party qualifications and governance oversight as a technical QA SME in the evolving digital and innovation landscape. This includes the initial qualification, routine risk monitoring and SME support during audits.
- Assist qualification and governance teams in identifying potential risks with new Third Parties, whether for GxP purposes or rapid ramp-up from exploratory to GxP use.
- Support the clinical trial team for trial specific assessment to ensure technology is fit for purpose based on specific study design.
- Responsible for review and approval of quality issues related to Third Party and ensure appropriate escalation of major and critical issues.
- Support assessment of serious breach and reporting to health authorities.
- Facilitate the ‘Quality with Technology’ discussions with Third Party management team and other interested parties to promote greater understanding of quality challenges when working with tech enabled Third Parties and overcome them through improved collaboration and awareness.
- Act as QA representative for cross-functional Digital Technology initiatives, managing the overall Third-Party Quality activities.
- Participate in the independent review of technology implementations ensuring inspection readiness and data integrity awareness.
- Ensure inspection readiness of outsourced related activities and support for internal and external audits and health authority (HA) inspections pertaining to Third Party management.
Minimum Requirements
- Extensive experience in pharmaceutical development and excellent knowledge of the quality management system, clinical operations processes and vendor management related activities is preferred.
- Minimum a bachelor’s degree in Life Sciences, Pharmacy or Medicine, M. Sc. IT/Engineering/Scientific discipline and/or Ph.D. in a Scientific and/or Engineering discipline preferred.
- Fluent English (both spoken & written).
- Working knowledge of GCP/GcLP, GVP, Medical Device regulations.
- Experience with clinical third-party management.
- Combination of computer system compliance and validation expertise associated with global IT systems development (SDLC) and implementation within the pharmaceutical and/or digital health technology (DHT).
- Broad knowledge of regulations and industry quality standards (GCP, ICH, FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485).
- Expertise in implementing DHT/SAMD technology within innovative clinical trials preferred.
- Experience navigating complex problems and developing solutions within a matrixed environment.
- Demonstrated ability to partake in interdisciplinary projects with a wide range of business functions and successfully work in a global cross-functional matrix.
Benefits & Rewards
At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: 63,917.00 - 118,703.00 GBP. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives.
Associate Director ESP Quality in London employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of London. As a Global Financial Controls & Compliance Process Experts Senior Manager, you will benefit from competitive compensation, flexible working options, and a commitment to employee growth through continuous learning and development opportunities. Join us in shaping the future of healthcare while enjoying a diverse and inclusive environment that values your contributions and well-being.
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We think this is how you could land Associate Director ESP Quality in London
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We think you need these skills to ace Associate Director ESP Quality in 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 Novartis 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 Novartis UK that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Novartis 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 Novartis UK that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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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.
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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.
