Director, Global Regulatory Affairs Process Excellence and Transformation

Vertex Pharmaceuticals•Boston, MA

8h•Hybrid

About The Position

The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA). The role is responsible for identifying, designing, and implementing process improvements that enhance efficiency, consistency, and quality across GRA processes. As a key member of the GRA Process Optimization Network (GPON), this role consults with cross-team representatives to diagnose operational challenges and deliver scalable, sustainable solutions. The Director applies deep subject-matter expertise and hands-on operational excellence experience to shape objectives and drive transformation aligned with GRA and corporate goals.

Requirements

Advanced knowledge of operational excellence methodologies and practical application of tools such as process mapping, root-cause analysis, value-stream mapping, and KPI development.
Strong expertise in developing and implementing process improvements across cross-functional teams.
Excellent written and oral communication skills, including the ability to facilitate workshops and present complex information to senior leaders.
Strong collaboration skills to effectively interact with internal and external stakeholders at all levels.
Ability to influence and drive alignment without formal authority.
Organizational skills and ability to manage multiple priorities.
Ability to drive firm deadlines.
Minimally requires a Bachelor's degree in Life Sciences or a related field.
10 years of experience or the equivalent combination of education and experience.
Experience within the Life Sciences industry or similar.
Hands-on experience applying operational excellence methodologies (e.g., Lean, Six Sigma, Kaizen) to deliver measurable process improvements.
Experience leading large, complex, cross-functional process optimization efforts in a global or matrixed environment.

Nice To Haves

An advanced degree is preferred.
Knowledge of regulatory processes, systems, and requirements is preferred.
Experience with digital workflow tools or process automation is a plus.
Experience working with regulatory processes strongly preferred.

Responsibilities

Lead complex GRA process improvement and transformation initiatives using structured operational excellence methodologies.
Drive cross-functional consultation through GPON and partner with GRA sub-functions to identify, prioritize, and solve critical business process challenges.
Define, standardize, and optimize end-to-end GRA processes, ensuring clarity, scalability, and alignment with organizational requirements.
Facilitate process mapping, root-cause analysis, scenario planning, and solution development activities across GRA.
Develop and implement change management plans, training, communication, and adoption strategies to ensure sustainable process implementation.
Partner with governance forums and senior leaders to ensure process improvements support GRA operational needs and corporate priorities.
Create, maintain, and enhance process documentation including playbooks, workflows, templates, and RACIs.
Establish performance metrics, dashboards, and reporting to measure process health, adoption, and continuous improvement opportunities.
Collaborate across GRA, Program Leadership, and adjacent functions to ensure optimized processes integrate effectively across the development continuum.
Provide operational excellence coaching and capability building across GRA teams to strengthen process maturity and execution efficiency.

Benefits

medical, dental and vision benefits
generous paid time off (including a week-long company shutdown in the Summer and the Winter)
educational assistance programs including student loan repayment
a generous commuting subsidy
matching charitable donations
401(k)

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume