Principal, Quality Consulting Services

IQVIA•Coral Gables, FL

21h•$140,200 - $390,600

About The Position

The Principal, Quality Consulting Services serves as a senior client-facing leader responsible for delivering strategic quality and regulatory consulting services to life sciences, medical device, diagnostics, and pharmaceutical clients. The role combines executive-level client advisory responsibilities, project leadership, business development, and thought leadership to help clients improve quality systems, achieve regulatory compliance, prepare for inspections, and address complex quality challenges.

Requirements

Bachelor's degree required.
10+ years of quality, regulatory, or compliance experience within life sciences, pharmaceutical, biotechnology, medical device, or diagnostics organizations.
Significant consulting experience leading client engagements.
Demonstrated success managing executive-level client relationships.
Proven business development and practice growth experience.
Experience supporting FDA inspections, remediation programs, and quality system transformations.
Executive presence and influence.
Strategic problem solving and consulting skills.
Proposal development and solution selling.
Financial and project management acumen.
Team leadership and mentoring.
Excellent written and verbal communication skills.
Ability to navigate complex client environments and competing priorities.

Nice To Haves

Advanced degree (MS, MBA, MPH, or equivalent) preferred.

Responsibilities

Serve as the executive lead for consulting engagements, ensuring client satisfaction, delivery quality, and business outcomes.
Advise senior client stakeholders on quality strategy, compliance risk, remediation programs, and quality system effectiveness.
Lead complex regulatory compliance, inspection readiness, validation, and quality transformation initiatives.
Manage multiple concurrent engagements, budgets, timelines, and project teams.
Provide strategic oversight while ensuring high-quality deliverables and practical implementation recommendations.
Identify, shape, and close new consulting opportunities.
Support proposal development, solution design, and client presentations.
Expand existing client relationships through follow-on work and cross-selling of Compliance & Quality services.
Monitor industry and regulatory trends to develop new service offerings and market strategies.
Contribute to revenue growth, utilization targets, and practice expansion.
Provide leadership and expertise in areas such as FDA regulatory compliance, 483 and Warning Letter remediation, Consent Decree support, Quality Management Systems (QMS), ISO 13485 and global quality standards, Inspection readiness and mock inspections, CAPA and root cause investigations, Post-market quality and vigilance, Process validation and equipment qualification, Computerized systems validation, Risk management and quality system assessments, Lean quality and operational excellence initiatives.
Mentor consultants, managers, and associate principals.
Develop methodologies, tools, and best practices.
Represent the practice through thought leadership, conference presentations, publications, and industry engagement.
Collaborate across IQVIA business units to create integrated client solutions.