Director, Global Regulatory Affairs Process Excellence And Transformation (Biotech)

TL;DR

Director, Global Regulatory Affairs Process Excellence and Transformation (Biotech): Leading complex, cross-functional operational excellence initiatives across Global Regulatory Affairs with an accent on process optimization, standardization, and transformation. Focus on diagnosing operational challenges, implementing scalable solutions, and driving process maturity through methodologies like Lean and Six Sigma.

Location: Must be based in Boston, MA; hybrid position requiring 3 days/week onsite.

Salary: $184,800–$277,200

Company

Vertex is a global biotechnology company that invests in scientific innovation.

What you will do

• Lead complex GRA process improvement and transformation initiatives using structured operational excellence methodologies.
• Drive cross-functional consultation through the GRA Process Optimization Network (GPON) to solve critical business process challenges.
• Define, standardize, and optimize end-to-end GRA processes to ensure scalability and alignment.
• Develop and implement change management plans, training, and adoption strategies.
• Establish performance metrics, dashboards, and reporting to measure process health and continuous improvement.
• Provide operational excellence coaching and capability building across GRA teams.

Requirements

• Must be based in or able to commute to Boston, MA (3 days/week onsite).
• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• Minimum 10 years of experience in Life Sciences or similar industry.
• Hands-on experience applying operational excellence methodologies (e.g., Lean, Six Sigma, Kaizen).
• Proven experience leading large, complex, cross-functional process optimization efforts in a global or matrixed environment.
• Strong communication and influence skills to drive alignment without formal authority.

Nice to have

• Knowledge of regulatory processes, systems, and requirements.
• Experience with digital workflow tools or process automation.

Culture & Benefits

• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including company-wide summer and winter shutdowns.
• Educational assistance programs, including student loan repayment.
• 401(k) retirement plan with company matching.
• Commuting subsidy and charitable donation matching.