Regulatory Requirements System Integrity Solutions Director (Life Science)

Location: Boston, United States; travel up to 25% based on client needs.

Compensation Range: $141,900–$286,000 annually, plus eligibility for a discretionary performance bonus.

Company

hirify.global provides professional services to middle-market organizations, including business application risk, governance, security, data, compliance, and regulatory validation solutions.

What you will do

• Lead a cross-functional team of governance, risk, application security, data, controls, and FDA validation specialists.
• Develop validation strategies, master plans, SOPs, enabling technologies, and validation testing for life-science clients.
• Review business application designs across SAP, Oracle, NetSuite, and D365 to ensure regulatory, traceability, compliance, and control requirements are incorporated.
• Establish governance frameworks, risk and control matrices, access-control strategies, and data-integrity safeguards throughout implementation lifecycles.
• Resolve regulatory and compliance issues, approve deliverables, communicate program risks, and manage mitigation efforts with client executives.
• Manage engagement contracting, budgeting, forecasting, financial reporting, delivery resources, and profitability while developing internal methodologies and new business opportunities.

Requirements

• FDA validation readiness experience and proficiency in FDA, GxP, and GMP IT validation.
• Experience applying regulatory requirements to large business-system deployments in the life-sciences industry, including SAP, NetSuite, Oracle, or D365.
• At least 12 years of experience in highly regulated program risk management for large transformations, with a strong understanding of the software development lifecycle.
• Undergraduate degree in business administration, program management, business operations, MIS, accounting, auditing, entrepreneurship, or a related field.
• Professional certification is required, along with experience leading multidisciplinary teams, communicating with executives, and managing organizational change.
• Ability to identify automation opportunities using GRC tools, automated testing, and AI-enabled documentation accelerators.

Nice to have

• Background in IT auditing.
• Chief of Staff certification.

Culture & Benefits

• Competitive compensation and benefits package.
• Flexible scheduling to support work-life balance while serving clients.
• Discretionary bonus based on firm and individual performance.
• Commitment to equal opportunity, professional ethics, integrity, and workplace accommodations.