GCP Compliance & Operational Excellence Consultant

Just In Time GCP; Warrington Township (Bucks County); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation

Work-life balance

Comprehensive Healthcare

Retirement savings plan

Collaborative culture

Job summary

Just in Time GCP is seeking a Consultant, Clinical Compliance & Operational Excellence to guide GCP compliance engagements across the life sciences industry. You will lead process reviews, risk assessments, and SOP development while collaborating with client teams to ensure inspection readiness and regulatory alignment.

The ideal candidate has 4–6 years of clinical operations or compliance experience, with strong knowledge of GCP, ICH, and Health Authority expectations.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• 4–6 years of experience in clinical development, clinical operations, or clinical compliance with focus on GCP, quality, and/or inspection readiness.
• Strong understanding of GCP, ICH, inspection readiness, and Health Authority regulations (FDA, EMA, MHRA) and ability to apply them operationally.
• Experience conducting compliance assessments, risk evaluations, and inspection readiness reviews with remediation planning.
• Experience supporting or leading Health Authority inspections or sponsor audits, including readiness planning and issue tracking.
• Strong analytical, critical-thinking, and problem-solving skills with ability to identify gaps and develop pragmatic solutions.
• Excellent written and verbal communication abilities for client-ready deliverables (SOPs, reports, summaries, presentations).
• Ability to work collaboratively across cross-functional teams to achieve project goals and support business development.

Responsibilities

• Lead or support consulting engagements focused on GCP compliance, inspection readiness, and process optimization.
• Conduct process reviews, gap analyses, and risk assessments; develop actionable recommendations and SOPs aligned with ICH E6 (R2/R3), 21 CFR Part 11, and global GCP standards.
• Facilitate client workshops and meetings to guide project activities and promote adoption of compliant practices.
• Prepare consulting deliverables such as SOP development, assessment analyses, compliance plans, and inspection readiness summaries.
• Support clients in inspection readiness activities including documentation review and remediation implementation.
• Collaborate with stakeholders to align project scope, priorities, and quality standards.
• Stay informed of evolving regulatory guidance and inspection trends to inform consulting recommendations.
• Identify opportunities to enhance consulting methodologies and delivery approaches.
• Contribute to business development through proposal support and client presentations.

Skills

GCP compliance

Regulatory knowledge

Process optimization

SOP development

Client communications

Education

Bachelor's degree in Life Sciences

Job description

Just in Time GCP is seeking a Consultant, Clinical Compliance & Operational Excellence to guide GCP compliance engagements across the life sciences industry. You will lead process reviews, risk assessments, and SOP development while collaborating with client teams to ensure inspection readiness and regulatory alignment.

The ideal candidate has 4–6 years of clinical operations or compliance experience, with strong knowledge of GCP, ICH, and Health Authority expectations.