GCP Clinical Compliance & Operational Excellence Consultant

Just In Time GCP; Warrington Township (Bucks County); Hybrid; USD 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Remote and hybrid roles available

Competitive compensation

Comprehensive healthcare

PTO & holidays

Retirement plan with company match

Collaborative culture

Zusammenfassung

Just in Time GCP seeks a Consultant, Clinical Compliance & Operational Excellence to join our life sciences team in the United States. You will lead or support engagements focused on GCP compliance, inspection readiness, and process optimization, delivering high-quality client deliverables.

Ideal candidates have 4–6 years in clinical development or compliance, strong knowledge of FDA/ICH, and the ability to translate regulatory requirements into practical improvements.

Qualifikationen

• Experience with GCP, ICH E6 (R2/R3), FDA/EMA/MHRA regulations.
• Experience conducting risk assessments and remediation planning.
• Experience supporting Health Authority inspections or sponsor audits.

Aufgaben

• Lead or support consulting engagements focused on GCP compliance, inspection readiness, and process optimization.
• Conduct process reviews, gap analyses, and risk assessments with actionable recommendations.
• Facilitate client workshops, stakeholder meetings, and cross-functional sessions to guide project activities.
• Prepare consulting deliverables such as SOPs, assessment analyses, and inspection readiness summaries.
• Support clients in inspection readiness activities, including documentation review and risk mitigation.
• Collaborate with clients and team to ensure alignment on scope and quality standards.

Kenntnisse

GCP compliance

inspection readiness

process optimization

risk assessments

SOP development

client workshops

regulatory knowledge

communication

Ausbildung

Bachelor’s degree in Life Sciences

Advanced degree preferred

Jobbeschreibung

Just in Time GCP seeks a Consultant, Clinical Compliance & Operational Excellence to join our life sciences team in the United States. You will lead or support engagements focused on GCP compliance, inspection readiness, and process optimization, delivering high-quality client deliverables.

Ideal candidates have 4–6 years in clinical development or compliance, strong knowledge of FDA/ICH, and the ability to translate regulatory requirements into practical improvements.