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.

Key Responsibilities

Client Leadership & Delivery

• 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.

Business Development

• 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.

Subject Matter Expertise

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

Practice Leadership

• 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.

Qualifications:

Education

• Bachelor's degree required.
• Advanced degree (MS, MBA, MPH, or equivalent) preferred.

Experience

• 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.

Skills

• 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.

Success Profile

A successful Principal is viewed as:

• A trusted advisor to client executives.
• A recognized subject matter expert in quality and compliance.
• A leader who consistently grows revenue and expands client relationships.
• A mentor who develops future consulting leaders.
• A driver of innovation and new service offerings within the Quality & Compliance practice.

Typical KPI Expectations

• Client satisfaction and engagement outcomes
• Consulting revenue and sales pipeline contribution
• Utilization and project profitability
• Expansion of strategic accounts
• Thought leadership contributions
• Team development and talent retention

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.