Quality Systems and Enterprise Management Projects Lead

Job Description

About This Role:

As the Quality Systems and Enterprise Management Projects Lead at Biogen, you will report directly to the Head of Quality Systems and Enterprise Management. Your primary focus will be the deployment of Enterprise-wide Systems and Quality Management System (QMS) projects that span across multiple functional areas of the organization. This critical individual contributor role includes strategizing, planning, and communicating with senior leadership and stakeholders on enterprise systems and process improvement projects. Your efforts will drive project proposals, manage deliverables, budgets, and monitor progress, ensuring risk mitigation and timely issue resolution.

As the Organizational Communication Management Lead, you will spearhead change management plans, fostering the adoption of projects led by the Corporate Quality Systems and Enterprise Management team. You will be pivotal in defining and reporting on the implementation of global, enterprise-wide Quality projects and activities, thereby contributing immense value to Biogen’s overarching business goals and quality objectives.

This is a hybrid role to be based at our office in Research Triangle Park, NC.

What You’ll Do:

• Develop and execute a disciplined project management approach, covering all aspects from schedule to budget, in collaboration with IT leads.
• Engage the business through comprehensive communication plans, facilitate key meetings, and oversee process-level meetings to drive Veeva implementation.
• Create and distribute program information to stakeholders, ensuring effective communication and timely decision-making.
• Lead change management strategies, motivate and align company-wide efforts to adopt Veeva, and foster a culture of collaboration and decisiveness.
• Generate dashboards, reports, and summaries to assist executive and operational level engagement and decision-making.
• Partner with stakeholders and Subject Matter Experts (SMEs) to assess program progress, reflect business issues, and report on engagement metrics.
• Manage project workspaces and discussion boards, conduct engagement and adoption assessments, and respond promptly to inquiries.
• Collaborate with QMS owners/leaders to drive process improvements, ensure business process decisions are timely, and implement harmonized QMS practices.
• Align Project Velocity with the One QMS strategic priority, monitoring interdependencies, resources, timelines, and risks.

Qualifications

Who You Are:
You are a seasoned professional with a background in life sciences or engineering with program and project management experience within the pharmaceutical industry. With your extensive experience with enterprise-wide applications, especially Veeva, you are prepared to lead complex projects with strategic importance. You have a track record of success in quality, safety, or regulatory roles and are adept at managing transformational changes within a regulated environment. You possess excellent communication skills, can distill complex information into clear, actionable messages, and can influence positive change across multiple levels of an organization.

Required Skills:

• Bachelor’s degree in life sciences, engineering or related.
• Minimum of 8-10 years of program and project management experience at mid/large size pharmaceutical companies. At least 5 years of experience should be in the Pharma/regulated industry focusing on quality, safety, or regulatory functions.
• Strong experience with enterprise-wide applications.
• Comprehensive understanding of life cycle management of enterprise-wide systems and business planning.
• Excellent communication skills, with the ability to engage various levels within an organization.
• Proven ability to influence change and drive decision-making with accountability.
• Skilled in fostering decision-making behaviors based on program structure and roles.
• Demonstrated ability to synthesize large amounts of information into key messages.

Preferred Skills:

• Experience across GxPs and QMS in large pharma.
• Veeva experience strongly desired and/or other large-scale cloud-based applications.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to de