Consultant, Clinical Compliance & Operational Excellence

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

Join the Just in Time GCP Team

At Just in Time GCP, we simplify clinical compliance to clear the path forward for biotech and pharma sponsors. Our work helps organizations meet GCP expectations with confidence so that compliance never slows down progress. We're currently looking for a Consultant, Clinical Compliance & Operational Excellence to join our team of experts delivering high-quality support across the life sciences industry.

What You’ll Do

• Lead or support consulting engagements focused on GCP compliance, inspection readiness, and process optimization, ensuring high-quality client deliverables and adherence to regulatory expectations
• Conduct process reviews, gap analyses, and risk assessments, developing actionable recommendations and contributing to SOP and procedural document development aligned with ICH E6 (R2/R3), 21 CFR Part 11, and global GCP standards
• Facilitate and participate in client workshops, stakeholder meetings, and cross-functional working sessions to guide project activities and promote adoption of compliant and efficient practices
• Prepare and contribute to consulting deliverables such as SOP development, assessment analysis, compliance plans, inspection readiness summaries, and supporting materials
• Support clients in inspection readiness activities, including documentation review, risk mitigation, and remediation implementation as applicable
• Collaborate with Just in Time GCP and client stakeholders to ensure alignment on project scope, priorities, and quality standards
• Stay informed of evolving regulatory guidance, inspection trends, and Health Authority expectations, integrating insights into Just in Time GCP's consulting recommendations
• Identify and recommend opportunities to enhance Just in Time GCP's consulting methodologies, templates, and delivery approaches
• Contribute to business development through proposal support, client presentations, and participation in solution design discussions.

What You Bring

• Bachelor's degree in Life Sciences, Quality Management, or a related field required; advanced degree preferred
• 4-6 years of experience in clinical development, clinical operations, or clinical compliance, with a focus on GCP, quality, and/or inspection readiness
• Strong understanding of GCP, ICH, inspection readiness, and Health Authority regulations (e.g., FDA, EMA, MHRA), with the ability to apply them effectively in operational settings
• Experience conducting compliance assessments, risk evaluations, and inspection readiness reviews, including remediation planning and recommendations for improvement
• 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 the ability to identify compliance gaps and develop pragmatic solutions
• Excellent written and verbal communication abilities, with experience preparing concise, client-ready deliverables such as SOPs, reports, summaries, and presentations
• Demonstrated ability to work collaboratively across cross-functional Just in Time GCP and client teams to achieve project goals
• Contribute to business development through high-quality project delivery, building strong client relationships, identifying potential opportunities for service expansion, and sharing observations that support Just in Time GCP's growth initiatives

You’ll thrive here if you value high-quality outcomes, communicate with clarity, and embrace innovation to make an impact.

Why Choose Just in Time GCP for Your Next Career Move?

• Community. We build meaningful relationships with our employees, clients, and partners, fostering a collaborative environment where everyone feels supported, valued, and empowered
• Pioneer. We lead with curiosity and innovation, continuously seeking better ways to solve complex challenges
• Premier. We are committed to excellence, delivering high-quality solutions that exceed expectations
• Steadfast. We act with integrity and reliability, standing firm in our commitment to our clients, our team, and our mission

You’ll be part of a team that values people, purpose, and performance in equal measure.

What You’ll Enjoy as Part of Our Team

• 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.

Location Requirement

To be eligible for consideration, candidates must reside in one of the following states: Pennsylvania, North Carolina, Kansas, Missouri, Florida, Indiana, South Carolina, Massachusetts, Texas, Georgia or New Jersey.

Applicants must be authorized to work in the United States at the time of application. We do not offer visa sponsorship and are not considering candidates with F-1/OPT work authorization.