We are seeking an exceptional Partner-level candidate to join our clients Life Sciences consulting team, specialising in Quality Assurance (QA) and Regulatory Affairs (RA), GAMP (Good Automated Manufacturing Practice), Software Validation within the Pharmaceutical and MedTech industries. The ideal candidate will bring extensive expertise in navigating complex regulatory frameworks, driving quality excellence, and delivering strategic solutions to our global clients. This senior role offers the opportunity to lead transformative projects for global life sciences clients, drive business development, and shape innovative solutions that address critical industry challenges.
The Opportunity:
Responsibilities
Strategic Leadership
* Lead high-impact engagements within the life sciences sector, focusing on QA/ RA strategies, Regulatory Operations (RIM implementation), Quality Management System implementation and improvements, and manufacturing excellence.
* Provide strategic guidance to clients on GAMP, developing and implementing innovative QA and RA strategies to ensure client compliance with global regulatory and quality requirements (e.g. FDA, EMA, MHRA, ISO, MDR/IVDR).
* Serve as a thought leader in QA and RA, shaping the firm’s approach to emerging trends and best practices in life sciences.
Business Development
* Identify and cultivate new business opportunities, including large-scale transformation engagements in the Life Sciences sector.
* Develop proposals, lead pitches, and drive revenue growth.
Team Leadership and Development
* Build and mentor a high-performing team of consultants with expertise in QA and RA.
* Foster a culture of collaboration, innovation, and continuous improvement.
Technical Expertise and Innovation
* Lead the validation of automated systems in line with GAMP guidelines and ensure adherence to industry-specific software validation standards.
* Drive the adoption of advanced technologies for QA and RA, including:
* Digital transformation initiatives for regulatory compliance and quality management systems.
* Automation of regulatory submissions, change control, and lifecycle management processes.
* Deliver innovative compliance solutions tailored to emerging areas such as personalised medicine, AI/ML, digital health, and combination products.
* Oversee the deployment and optimisation of quality and compliance platforms, including QMS (Quality Management Systems), eCTD, and RIM tools, ensuring alignment with global regulatory requirements (e.g., GxP, RBQM, QbD, ISO 13485, 21CFR 820, EU MDR/IVDR).
* Lead the implementation and optimisation of Regulatory Information Management (RIM) systems, ensuring seamless integration with broader enterprise platforms to enhance regulatory processes and data integrity.
Qualifications
* Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related discipline.
* Significant experience (10+ years) in management consulting or senior leadership roles within the life sciences industry.
* Demonstrated success in a leadership role, including P&L responsibility, client relationship management, and team development.
* Deep knowledge of global regulatory standards and quality systems (e.g., GxP, ISO 13485, EU MDR/IVDR).
* Exceptional communication, negotiation, and presentation skills.
* Strong track record of driving business growth and building trusted client relationships.