Strategic Consultant, Clinical Compliance & Operational Excellence

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 Strategic Consultant, Clinical Compliance & Operational Excellence to join our team of experts delivering high-quality support across the life sciences industry.

What You’ll Do

In this role, you’ll contribute to our mission of helping clients build strong, inspection-ready systems and processes. Responsibilities include:

• Lead complex consulting engagements focused on GCP compliance, clinical operations optimization, and inspection readiness, ensuring alignment with client objectives and global regulatory expectations
• Serve as a senior subject matter expert (SME) and trusted advisor to clients on GCP, ICH, and Health Authority requirements, providing strategic direction and regulatory insight across multiple programs
• Oversee the development and quality of project deliverables, ensuring consistency, accuracy, and strategic alignment across Just in Time GCP engagements
• Design and deliver GCP and inspection readiness training programs for client teams to strengthen compliance culture and operational preparedness
• Conduct or lead compliance assessments, risk analyses, and process evaluations, identifying trends and developing recommendations that drive efficiency and quality improvement
• Facilitate executive-level workshops and strategy sessions to guide client leadership on compliance frameworks, organizational readiness, and sustainable quality practices
• Partner with Just in Time GCP leadership to enhance consulting methodologies, tools, and best practices, driving innovation and excellence across service offerings
• Monitor and interpret emerging regulatory trends, inspection outcomes, and Health Authority guidance, translating insights into strategic recommendations for clients and Just in Time GCP
• Mentor and guide consultants and senior consultants, providing subject matter expertise and oversight to support their development and ensure high-quality project execution
• Contribute to business development through proposal leadership, client engagement, and identifying opportunities for expanded services or strategic partnerships
• Represent Just in Time GCP through thought leadership activities, including conference presentations, webinars, or publications that elevate Just in Time GCP’s reputation in clinical compliance and operational excellence

What You Bring

You’ll thrive here if you value high-quality outcomes, communicate with clarity, and embrace innovation to make an impact. We’re looking for someone who brings a combination of expertise, initiative, and collaboration. Ideal candidates will have:

• Bachelor’s degree required; advanced degree preferred in Life Sciences, Quality Management, or related field
• 10–12 years of experience in clinical operations, clinical compliance, and/or consulting, including substantial experience advising on GCP and inspection readiness
• Recognized expertise in ICH, GCP, 21 CFR Part 11, Annex 11, and international regulatory frameworks governing clinical research and quality systems
• Demonstrated success overseeing complex compliance initiatives or multi-functional programs in regulated life sciences environments
• Proven ability to develop and deliver GCP and inspection readiness training programs for diverse client or internal audiences
• Strong analytical and strategic thinking skills with the ability to translate regulatory expectations into actionable, scalable solutions
• Experience supporting or leading Health Authority inspections (FDA, EMA, MHRA, etc.) and contributing to inspection readiness strategies and post-inspection improvements
• Excellent executive communication and facilitation skills, capable of engaging and influencing senior stakeholders across organizations
• Demonstrated mentorship and leadership capabilities with commitment to developing others and maintaining Just in Time GCP’s culture of excellence
• Strong business acumen, with the ability to identify and shape client growth opportunities through delivery excellence and strategic insight

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

At Just in Time GCP, we take pride in knowing our work helps bring safe, effective treatments to patients faster. Our team operates in a dynamic, results-driven environment shaped by our core values. 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: Paid time off, 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 of passionate professionals who love what they do and work together to make a difference

Location Requirement

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

Ready to Make an Impact?

If this sounds like the right fit, we invite you to apply and join a team that’s moving clinical research forward with confidence.

Just in Time GCP endeavors to make the application process accessible to all users. If you need assistance completing the application process, please contact Just in Time GCP Human Resources at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

Just in Time GCP is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 

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 H-1B or F-1/OPT work authorization.