Director, Compliance Consulting Practice Lead jobs in United States
cer-icon
Apply on Employer Site
company-logo

Just in Time GCP ยท 1 month ago

Director, Compliance Consulting Practice Lead

Just in Time GCP simplifies clinical compliance for biotech and pharma sponsors, helping them meet GCP expectations confidently. The Director, Compliance Consulting Practice Lead will be responsible for leading the GCP Compliance Consulting Practice, developing consulting products, and driving business growth while mentoring a team of consultants.

ConsultingQuality AssuranceTraining
badNo H1BnoteU.S. Citizen Onlynote

Responsibilities

Lead Just in Time GCP's GCP Compliance Consulting Practice, including strategic direction, team management, and client delivery excellence
Oversee development of GCP consulting products aligned with ICH E6(R3), including frameworks for oversight, risk management, and data integrity
Expand and commercialize Just in Time GCP's Inspection Readiness Program, ensuring it serves as a key entry point for inspection readiness engagements
Partner with eClinical and Strategy practice leads to deliver cross-vertical consulting solutions that integrate compliance, technology, and change management
Build and mentor a team of GCP consultants equipped to deliver world-class consulting services to global sponsors and CROs
Represent Just in Time GCP as a thought leader through speaking engagements, publications, and participation in industry collaborations
Drive business growth through new client development, account expansion, and the introduction of new compliance products and methodologies

Qualification

GCP complianceQuality managementClinical operationsICH E6(R2/R3)Risk-based quality managementInspection readinessBusiness acumenSales supportTeam managementLeadership skillsCommunication skillsCollaboration skills

Required

Bachelor's degree in life sciences or related field
12+ years of experience in GCP compliance, quality management, or clinical operations
Deep knowledge of ICH E6(R2/R3), risk-based quality management, and inspection readiness principles
Proven ability to develop consulting solutions and manage teams in a dynamic, client-facing environment
Strong business acumen with experience in sales support and account growth
Excellent leadership, communication, and collaboration skills

Preferred

Advanced degree preferred

Benefits

Flexible Work Environment -- Remote and hybrid roles available
Competitive Compensation -- Reflective of your skills and the value you bring
Work-Life Balance -- PTO, paid holidays, and summer half-day Fridays
Comprehensive Healthcare -- Medical, dental, vision, life insurance, and income protection
Retirement Savings Plan -- Includes a company match
Collaborative Culture -- Join a team that enjoys what we do and supports one another

Company

Just in Time GCP

twittertwitter
company-logo
Just in Time GCP is an innovative approach to developing processes that support compliance and ensure a high-quality TMF.

Funding

Current Stage
Growth Stage

Leadership Team

leader-logo
Ashley E. Bates
Sr. Director Consulting & Partnerships
linkedin
Company data provided by crunchbase