The Director, Global Regulatory Affairs Process Excellence & Transformation leads complex, cross-functional operational excellence initiatives across Global Regulatory Affairs (GRA). Responsible for identifying, designing, and implementing process improvements that enhance efficiency, consistency, and quality across GRA processes. Boston-based, hybrid (3 days/week onsite).
Key Duties & Responsibilities:
- Lead complex GRA process improvement and transformation initiatives using operational excellence methodologies.
- Drive cross-functional consultation through GPON; partner with GRA sub-functions to identify, prioritize, and solve business process challenges.
- Define, standardize, and optimize end-to-end GRA processes.
- Facilitate process mapping, root-cause analysis, scenario planning, and solution development.
- Develop and implement change management plans, training, communication, and adoption strategies.
- Partner with governance forums and senior leaders.
- Create and maintain process documentation (playbooks, workflows, templates, RACIs).
- Establish performance metrics, dashboards, and reporting.
- Collaborate across GRA, Program Leadership, and adjacent functions.
- Provide operational excellence coaching and capability building.
Knowledge and Skills (Preferred/Plus):
- Operational excellence methods (process mapping, root-cause analysis, value-stream mapping, KPI development).
- Cross-functional process improvement expertise.
- Strong written/oral communication; workshop facilitation.
- Ability to influence without formal authority; organizational skills.
- Knowledge of regulatory processes/systems (preferred).
- Digital workflow tools/process automation (plus).
- Ability to drive firm deadlines.
Education and Experience:
- Bachelorβs in Life Sciences or related field (advanced degree preferred).
- 10+ years experience (or equivalent).
- Life Sciences industry experience.
- Hands-on Lean/Six Sigma/Kaizen experience.
- Experience leading large, complex cross-functional process optimization in global/matrixed environments.
- Regulatory processes experience (strongly preferred).
Pay Range:
- $184,800 - $277,200
Application Instructions:
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for application accommodation requests.