Develop, implement, and lead a data
and metric-driven leadership approach under a target operating model for protein-based products
Ensure alignment with risk management principles and regulatory guidelines, including ICH Q8, Q9, Q10 and others
Provide leadership for all protein-based products from a Quality Assurance perspective
Oversee and guide critical product changes related to regulatory compliance, quality, safety, efficacy, manufacturing sites, technology transfers, and commercial preparations and launches
Lead and manage critical product deviations with potential impacts on regulatory compliance, quality, safety, efficacy, manufacturing sites, technology transfers, and commercial preparations and launches
Provide strong leadership to a team of Quality Assurance professionals, fostering a culture of collaboration, accountability, and excellence

A degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related field
Advanced degrees (e.g., MSc, PhD, MBA) are highly desirable
Extensive experience in R&D Quality or Product Quality
Proven track record of leading through product challenges related to compliance and quality and product launches
Deep understanding of ICH guidelines (Q8, Q9, Q10) and their application in protein product development and lifecycle management
Long-term business and pharmaceutical understanding with the ability to anticipate and navigate strategic and tactical challenges in product development and commercialization
Proven ability to lead and develop teams
Exceptional analytical and problem-solving skills
Excellent communication and interpersonal skills

Senior Director – Protein Modality Lead

Key skills