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 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: 1. Lead or support consulting engagements focused on GCP compliance, inspection readiness, and process optimization, ensuring high-quality client deliverables and adherence to regulatory expectations 2. 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 3. 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 4. Prepare and contribute to consulting deliverables such as SOP development, assessment analysis, compliance plans, inspection readiness summaries, and supporting materials 5. Support clients in inspection readiness activities, including documentation review, risk mitigation, and remediation implementation as applicable 6. Collaborate with Just in Time GCP and client stakeholders to ensure alignment on project scope, priorities, and quality standards 7. Stay informed of evolving regulatory guidance, inspection trends, and Health Authority expectations, integrating insights into Just in Time GCP's consulting recommendations 8. Identify and recommend opportunities to enhance Just in Time GCP's consulting methodologies, templates, and delivery approaches 9. Contribute to business development through proposal support, client presentations, and participation in solution design discussions. ## What You Bring We're looking for someone who brings a combination of expertise, initiative, and collaboration. Ideal candidates will have: 1. Bachelor's degree in Life Sciences, Quality Management, or a related field required; advanced degree preferred 2. 4-6 years of experience in clinical development, clinical operations, or clinical compliance, with a focus on GCP, quality, and/or inspection readiness 3. 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 4. Experience conducting compliance assessments, risk evaluations, and inspection readiness reviews, including remediation planning and recommendations for improvement 5. Experience supporting or leading Health Authority inspections or sponsor audits, including readiness planning and issue tracking 6. Strong analytical, critical-thinking, and problem-solving skills with the ability to identify compliance gaps and develop pragmatic solutions 7. Excellent written and verbal communication abilities, with experience preparing concise, client-ready deliverables such as SOPs, reports, summaries, and presentations 8. Demonstrated ability to work collaboratively across cross-functional Just in Time GCP and client teams to achieve project goals 9. 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? At Just in Time GCP, we ta e 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: 1. Community. We build meaningful relationships with our employees, clients, and partners, fostering a collaborative environment where everyone feels supported, valued, and empowered 2. Pioneer. We lead with curiosity and innovation, continuously seeking better ways to solve complex challenges 3. Premier. We are committed to excellence, delivering high-quality solutions that exceed expectations 4. 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 1. Flexible Work Environment. Remote and hybrid roles available 2. Competitive Compensation. Reflective of your skills and the value you bring 3. Work-Life Balance. PTO, paid holidays, and summer half-day Fridays 4. Comprehensive Healthcare. Medical, dental, vision, life insurance, and income protection 5. Retirement Savings Plan. Includes a company match 6. 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. ## ## 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. 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. 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 applicat