Senior Manager, Business Analysis and Project Management

The Opportunity:

The Senior Manager, Business Analysis & Project Management is a strategic leadership role within the Information Sciences organization, responsible for driving enterprise technology initiatives that support pharmaceutical research, development, manufacturing, quality, and commercial operations. This role requires creation of business and Sciences requirements leading to delivery of complex, cross-functional projects while maintaining compliance with regulatory and validation requirements.

The role partners closely with business and IS leadership to translate business strategies into scalable, compliant technology solutions, while ensuring projects are delivered on time, within scope, and within budget.

Key Responsibilities:

Strategic Leadership & Governance

• Develop and execute the Business Analysis and Project Management strategy aligned with enterprise IS and business objectives.

• Establish and enforce standardized methodologies, templates, tools, and best practices (Agile, Waterfall, Hybrid).

• Provide portfolio-level oversight, prioritization, and delivery governance for IS initiatives.

• Serve as a trusted advisor to senior business and IT stakeholders.

Business Analysis & Stakeholder Partnership

• Lead business analysis activities, including facilitating workshops, to elicit, document, and validate complex business and functional requirements.

• Partner with stakeholders across R&D, Clinical, Regulatory, Quality, Manufacturing, Supply Chain, and Commercial functions to document and map current and future-state business processes.

• Identify process gaps, redundancies, and optimization opportunities including integrations.

• Ensure integration points and downstream impacts are identified and addressed.

• Analyze data flows across Sciences and functions.

• Translate business needs into clear, structured system requirements.

• Ensure solutions align with end-to-end business operations.

• Ensure traceability of requirements through design, development, testing, and deployment.

• Support user acceptance testing and validation.

• Drive data-driven decision-making and continuous process improvement.

Project & Program Management

• Lead planning and execution of multiple concurrent projects and programs of varying size and complexity.

• Manage project scope, schedule, budget, risks, issues, dependencies, and change control.

• Ensure alignment of project outcomes with business value realization.

• Oversee vendor performance, contracts, and delivery outcomes.

Compliance, Validation & Risk Management

• Ensure all IS projects comply with pharmaceutical regulatory requirements (e.g., GxP, FDA, SOX, GDPR as applicable).

• Partner with Quality Assurance and the Computer System Validation team to support system validation, audits, and inspections.

• Identify, assess, and mitigate operational, technical, and compliance risks.

Required Skills, Experience and Education:

• Bachelor’s degree in Information Sciences, Computer Science, Business Administration, or related field (Master’s degree preferred).

• 10+ years of experience in Business Analysis, Project Management, or IS delivery roles.

• Experience working in a pharmaceutical, biotechnology, or life sciences environment.

• Proven success delivering complex, cross-functional enterprise Science.

• Strong understanding of SDLC, Agile, Waterfall, and hybrid delivery models.

• Experience with R&D, Commercial & MedAffairs and G&A systems.

• Expertise in requirements management, business process modeling, and solution design.

• Strong financial, risk, and vendor management skill.

• Working knowledge of GxP, system validation, and regulated system environments.

• Experience supporting audits and regulatory inspections.

Preferred Skills:

• PMP®, PgMP®, PMO-CP.

• CBAP®, CCBA®.

• Agile certifications (SAFe, Scrum Master, Product Owner).

• Lean Six Sigma Certifications.

#LI-Hybrid  #LI-YG1