Head of Regulatory Technology Practice

Company Description

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.  

Additional Information

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.