Director, Global Regulatory Affairs Process Excellence and Transformation

Vertex Inc. • Boston, MA

1d • 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. This is a Boston based, hybrid position requiring 3 days/week onsite.

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

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

• Annual bonus
• Annual equity awards
• Overtime pay (for some roles, in accordance with federal and state requirements)
• Inclusive market-leading benefits
• Medical benefits
• Dental benefits
• 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
• Generous commuting subsidy
• Matching charitable donations
• 401(k)
• Flexibility and resources to support growth and aspirations

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees