Senior Director, Business Operations Lead (Global Regulatory Affairs)

Job Description

The Senior Director Business Operations Lead is a key leadership role responsible for providing strategic direction and operational oversight across Global Regulatory Affairs (GRA). This role establishes and advances the frameworks capabilities and business systems needed to ensure effective and efficient operations across four areas of accountability: project management process excellence resource management and vendor management. The individual will oversee all GRA budget headcount and vendor activities ensuring alignment with organizational priorities and sustained operational excellence. This position leads a team of five direct reports responsible for supporting GRAs operational performance and for collaboratively planning managing and tracking Global Regulatory Affairs resources to most efficiently and effectively support department goals and obligations.

This is a Boston based hybrid position requiring 3 days/week onsite.

Key Duties & Responsibilities:

Project Management

• Ensures GRA resources are effectively allocated to the highestpriority projects and initiatives maintaining a clear portfolio view of current and future products to support ongoing prioritization and goal setting
• Identifies and prioritizes improvement opportunities based on data-driven insights.
• Provides strategic oversight of the GRA project management function ensuring disciplined execution integrated planning and transparency across initiatives.
• Oversees development and use of project management tools standards metrics and reporting to support business priorities.
• Facilitates cross-functional alignment escalations and decision-making with senior leadership.
• Ensures proactive identification mitigation and communication of project risks and resource constraints.

Process Excellence

• Leads development implementation and continual improvement of operational processes to drive quality efficiency and operational discipline.
• Applies Operational Excellence methodologies (e.g. Lean DMAIC root cause analysis) to improve workflows and address systemic challenges.
• Partners across GRA and other functions to harmonize processes and support operational maturity.

Resource Management (Budget & Headcount)

• Serves as the accountable leader for all GRA budget financial tracking and headcount planning ensuring visibility accuracy and adherence to organizational objectives.
• Leads the group responsible for collaboratively planning managing and tracking Global Regulatory Affairs resources to most efficiently and effectively support department goals and obligations.
• Oversees development of annual budgets and resource forecasts and monitors performance against plan.
• Provides strategic insights and recommendations to senior leadership regarding resource allocation staffing models and financial trends.
• Oversees workforce planning and staffing models in collaboration with functional leaders Finance and HR.
• Ensures clear accurate reporting of financial and resource metrics.

Vendor Management

• Partners with Strategic Source to oversee GRAs vendor qualification oversight and performance management program ensuring alignment with business needs and compliance expectations.
• Establishes governance frameworks KPIs and performance monitoring processes for all GRA vendors.
• Partners with Strategic Sourcing Legal QA and business leaders to ensure effective vendor engagement quality and cost efficiency.

People Management and Cross-Functional Engagement

• Manages a team of three direct reports providing coaching development and performance management.
• Builds and maintains effective partnerships with internal and external stakeholders and serves as a trusted advisor on operational matters.
• Anticipates the impact of evolving regulatory and business environments on GRA operations and recommends strategies to enhance readiness and effectiveness.
• Represents GRA with senior internal stakeholders and when appropriate external partners.

Knowledge and Skills:

• Demonstrated ability to lead complex operational functions and develop high-performing teams.
• Highly collaborative with strong ability to build effective working relationships and align cross-functional teams.
• Strong financial acumen with experience overseeing budgets resource plans and vendor portfolios.
• Experience applying operational excellence methodologies (Lean DMAIC Six Sigma root cause analysis).
• Skilled in project management planning risk assessment and performance reporting.
• Excellent verbal written and presentation communication skills.
• Comfortable operating in a fast-paced evolving environment.

Education and Experience:

• Bachelors degree in a scientific technical business or allied health field (or equivalent degree).
• Typically requires 12 years of relevant experience including 5 years of management experience or an equivalent combination of education and experience. Experience in business operations project management financial planning regulatory operations or related areas preferred.

#LI-TC1

#LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

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

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at