Senior Manager, Regulatory Operations, Business Excellence

Role Summary

The Senior Manager of Business Excellence drives the successful execution of Global Regulatory Operations Strategy & Innovation programs and projects in a highly regulated environment, interacting at all levels of the organization. The role requires leadership in process optimization and project management, with experience leading cross-functional teams to foster collaboration, innovation, and operational excellence.

Responsibilities

• Lead process improvement/optimization projects from inception to implementation to improve processes and efficiency within the organization.
• Monitor and support adoption and improvement of GROSI programs, systems, policies, procedures, and controls.
• Collaborate with cross-functional stakeholders to ensure processes and procedures remain compliant.
• Provide project management support on execution of the implementation plan with cross-functional teams.
• Support process mapping, maintain trackers, and publish metrics reports.
• Provide timely updates on projects and present strategic vision and status updates to senior management.
• Investigate workflows and pain points, propose end-state solutions, and secure buy-in from key stakeholders.
• Measure and refine the efficiency and utilization of new workflows.
• Develop collaborative relationships across the organization to identify future process improvement opportunities.
• Anticipate implications of actions and mitigate potential problems.

Qualifications

• Bachelor's Degree with 7+ years of IT, consulting, and/or project management experience required.
• 7+ years in the pharmaceutical/bio-pharmaceutical industry with prior Regulatory Operations experience preferred.

Skills

• Veeva Vault experience preferred
• Microsoft Office and Adobe systems
• Project management tools: Microsoft Project or Smartsheet
• Regulatory Information Management (RIM) systems (Veeva Vault, Liquent InSight, etc.)
• Collaboration tools (SharePoint, etc.)
• Data visualization tools (PowerBI, etc.)

Education

• No specific education beyond bachelor‚Äôs degree is indicated beyond the qualifications section; experience is emphasized.

Additional Requirements

• Resilient and able to deliver in an ambiguous environment.
• Strategic thinker focused on process improvement and optimization.
• Strong verbal and written communication, attention to detail, time management, prioritization, and problem-solving skills.
• Ability to balance multiple tasks to meet deadlines and customer expectations.
• Accountability, initiative, leadership, integrity, teamwork, and excellence as a standard.
• Ability to manage shifting priorities without compromising quality or timelines.
• Experience working independently and in groups; familiarity with pharmaceutical development and regulatory submissions is a plus.
• Excellent presentation and facilitation skills.
• Knowledge of regulations and standards governing regulated systems, records retention, computer validation, SDLC, CFR Part 11, and Annex 11 compliance.
• Ability to facilitate, lead, and establish procedures.
• Ability to work in a fast-paced environment and manage workload under pressure.