At a Glance
- Tasks: Lead GxP audits and consultancy for cutting-edge regulatory technologies in Pharma and Biotech.
- Company: Join ADAMAS, a leader in regulatory compliance for the global pharmaceutical industry.
- Benefits: Competitive salary, career development, and a supportive, diverse work environment.
- Other info: Work globally with a focus on personal and professional growth.
- Why this job: Make an impact in the evolving world of AI and regulatory compliance.
- Qualifications: Strong experience in AI/ML and management within regulated environments.
The predicted salary is between 80000 - 100000 € per year.
ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP). Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector. ADAMAS has an established client base with an expansive global reach, including North America, Europe, and Asia Pacific. We work with over 100 currently active clients and have worked with over 700 pharmaceutical companies, including 40 of the 50 largest global pharma and biotech companies.
At ADAMAS, our people are our primary asset. We possess the highest and broadest level of in-house knowledge and can deliver genuine expertise and experience globally via in-house resources. ADAMAS's success is down to the calibre of its people – to reward them we offer a competitive salary with benefits, excellent working conditions and a fulfilling and rewarding career, with plenty of opportunities for further development.
Job Description:
- Plan, conduct, and report GxP audits, including technology focused and computerised 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.
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. To succeed we must work together with a human first approach. Why? Because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- 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.
Our core values are key to how we operate, and if you feel they resonate with you then ADAMAS is a great place to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
Head of Regulatory Technology Practice in Guildford employer: Adamas Consulting
ADAMAS is an exceptional employer, offering a dynamic and supportive work environment where employees are valued as the primary asset. With a strong focus on personal and professional growth, competitive salaries, and comprehensive benefits, ADAMAS fosters a culture of collaboration and innovation, making it an ideal place for those looking to advance their careers in regulatory technology within the global pharmaceutical 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 people in the industry, attend relevant events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching ADAMAS and understanding their core values. Tailor your responses to show how your experience aligns with their mission and how you can contribute to their success in regulatory technology.
✨Tip Number 3
Showcase your expertise! Bring examples of your past work, especially related to AI/ML and GxP compliance, to the table during interviews. This will help demonstrate your value and how you can lead the Regulatory Technology Practice.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining the ADAMAS team.
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 and AI/ML, as well as any relevant management experience. We want to see how your skills align with what we do at ADAMAS!
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 mission. Be sure to mention specific experiences that relate to the job description.
Showcase Your Knowledge:In your application, demonstrate your understanding of industry standards like GAMP 5 and 21 CFR Part 11. We love candidates who are up-to-date with emerging trends in regulatory compliance, so don’t hold back on sharing your insights!
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 ADAMAS!
How to prepare for a job interview at Adamas Consulting
✨Know Your GxP Inside Out
Make sure you brush up on your knowledge of Good Clinical Practice, Good Pharmacovigilance Practice, and other GxP standards. Be ready to discuss how these apply to regulatory technology and compliance, as this will show your expertise and understanding of the industry.
✨Showcase Your AI/ML Experience
Since the role involves supporting clients with AI/ML in GxP settings, prepare specific examples of your experience in this area. Discuss any projects you've led or contributed to that involved AI/ML technologies, and how they impacted compliance and regulatory processes.
✨Demonstrate Leadership Skills
As a Head of Regulatory Technology Practice, you'll need strong management skills. Be prepared to share examples of how you've successfully led teams or projects in the past, focusing on your approach to mentoring and developing team members.
✨Engage with Industry Trends
Stay updated on emerging global regulatory expectations and industry trends related to digital systems and AI governance. Bring insights to the interview about how these trends could impact ADAMAS and its clients, showing that you're proactive and forward-thinking.
