At a Glance
- Tasks: Lead GxP audits and deliver consultancy on regulated technologies in Pharma and Biotech.
- Company: Dynamic firm focused on regulatory technology with a global reach.
- Benefits: Career development, supportive culture, and opportunities for international collaboration.
- Other info: Diverse workplace prioritising growth and inclusion.
- Why this job: Shape the future of AI/ML in regulated environments and drive impactful change.
- Qualifications: Strong experience in AI/ML and management within regulated environments.
The predicted salary is between 80000 - 100000 € per year.
Plan, conduct, and report GxP audits, including technology focused and computerized systems audits, as applicable, across Pharma, Biotech and Healthcare client base.
Deliver consultancy services relating to regulated technologies, including governance models, system oversight, risk assessments, compliance gap analyses and inspection readiness activities.
Support clients in the implementation and oversight of evolving regulatory expectations relating to AI/ML in GxP settings and risk based QA frameworks.
Monitor and interpret emerging global regulatory expectations and industry trends relating to Digital Systems, AI Governance, Data Oversight and technology enabled GxP compliance.
Provide strategic and operational leadership in the area of emerging technologies, practices and technology enabled regulatory compliance within GxP environments.
Lead the development and growth of the Regulatory Technology Practice across global Pharma, Biotech and Healthcare client base.
Collaborate with internal GxP Practices and Subject Matter Experts across CSC, GCP, GVP, GLP, and GMP to establish and integrate digital and technology focused solutions into broader service lines.
Drive business development activities through client engagement, proposal development, thought leadership and conference participation.
Mentor and support the development of team members within the Regulatory Technology Practice while contributing to the long term strategic direction and scalability of the service line.
Qualifications
- Strong AI/ML/CSV experience
- Demonstrated management experience
- Knowledge of validation of GxP computerized systems within regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, and applicable predicate regulations.
- Up to 40% travel and ability to conduct remote audits.
EEO Statement
As an organization, we prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language.
Head of Regulatory Technology Practice in Guildford employer: Ergomed Group
As a leading employer in the Pharma, Biotech, and Healthcare sectors, we offer an exceptional work environment that prioritises diversity, equity, and inclusion. Our commitment to personal and professional growth is reflected in our robust training and career development opportunities, alongside a friendly and supportive culture that encourages collaboration with colleagues globally. Join us to lead the way in regulatory technology while making a meaningful impact in a rapidly evolving industry.
StudySmarter Expert Advice🤫
We think this is how you could land Head of Regulatory Technology Practice in Guildford
✨Tip Number 1
Network like a pro! Reach out to industry professionals on LinkedIn or attend relevant conferences. We can’t stress enough how important it is to make connections that could lead to job opportunities.
✨Tip Number 2
Showcase your expertise! Create a portfolio or a blog where you discuss trends in regulatory technology and AI/ML. This not only highlights your knowledge but also makes you stand out to potential employers.
✨Tip Number 3
Prepare for interviews by practising common questions related to GxP audits and regulatory compliance. We recommend doing mock interviews with friends or mentors to boost your confidence.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Head of Regulatory Technology Practice in Guildford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Head of Regulatory Technology Practice role. Highlight your experience with GxP audits, AI/ML, and any relevant regulatory frameworks. We want to see how your skills align 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 passionate about regulatory technology and how you can contribute to our team. Be sure to mention specific experiences that relate to the job description.
Showcase Your Leadership Skills:Since this role involves strategic and operational leadership, don’t forget to highlight your management experience. Share examples of how you've led teams or projects in the past, especially in regulated environments.
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 team at StudySmarter!
How to prepare for a job interview at Ergomed Group
✨Know Your GxP Inside Out
Make sure you brush up on your knowledge of GxP regulations and standards, especially around AI/ML and computerized systems. Familiarise yourself with GAMP 5 and 21 CFR Part 11, as these will likely come up in conversation.
✨Showcase Your Consultancy Skills
Prepare to discuss your experience in delivering consultancy services. Think of specific examples where you've implemented governance models or conducted compliance gap analyses, and be ready to explain how you approached these challenges.
✨Stay Ahead of Industry Trends
Keep an eye on emerging global regulatory expectations and industry trends related to digital systems and AI governance. Being able to discuss recent developments will show that you're proactive and knowledgeable about the field.
✨Demonstrate Leadership and Mentorship
Be prepared to talk about your management experience and how you've supported team development in previous roles. Highlight any mentoring experiences and how you’ve contributed to strategic direction in your past positions.
