Talent.com
Strategic Consultant, Clinical Compliance & Operational Excellence

Strategic Consultant, Clinical Compliance & Operational Excellence

Pennsylvania StaffingWarrington, PA, US
1 day ago
Job type
  • Full-time
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 Strategic Consultant, Clinical Compliance & Operational Excellence to join our team of experts delivering high-quality support across the life sciences industry.

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

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 HR@justintimegcp.com. 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.

    Create a job alert for this search

    Operational Excellence • Warrington, PA, US

    Related jobs
    • Promoted
    Associate Director Clinical Safety Scientist

    Associate Director Clinical Safety Scientist

    JouléBasking Ridge, NJ, US
    Full-time
    Job Title : Associate Director, Clinical Safety Scientist (Contingent Worker) Job Schedule : Candidate can work 100% remote – preference would be EST / CST based candidates. Contract Duration : 6 months ...Show moreLast updated: 11 days ago
    • Promoted
    Compliance RN - Delegation Oversight

    Compliance RN - Delegation Oversight

    InteProsPhiladelphia, PA, US
    Full-time
    Compliance Specialist - Delegation Oversight.Philadelphia, PA (must hold active, unrestricted PA RN license).The Delegation Oversight Specialist – RN plays a key role in ensuring that all del...Show moreLast updated: 20 days ago
    • Promoted
    Licensed Behavioral Health Clinician

    Licensed Behavioral Health Clinician

    OptumHavertown, PA, United States
    Full-time
    Springfield Behavioral of Pennsylvania, part of the Optum family of businesses, is seeking Licensed Clinical Therapists to join our teams in Philadelphia, Havertown, Springfield, and Trevose, PA.As...Show moreLast updated: 30+ days ago
    • Promoted
    Manager, Clinical Operations

    Manager, Clinical Operations

    Harmony BiosciencesPlymouth Meeting, PA, United States
    Full-time
    Harmony Biosciences is recruiting for a.Manager, Clinical Trial Operations.In this role you will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and...Show moreLast updated: 2 days ago
    • Promoted
    Principal PBPK Consultant

    Principal PBPK Consultant

    Certara USA, Inc.Wayne, PA, United States
    Full-time
    Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharm...Show moreLast updated: 30+ days ago
    • Promoted
    Local Contract CMA - Clinic

    Local Contract CMA - Clinic

    Planet HealthcareSellersville, PA, US
    Full-time
    Planet Healthcare is seeking a CMA Clinic for a local contract job in Sellersville, Pennsylvania.Job Description & Requirements. Busy cardiology practice at one of the Top Hospital Systems in th...Show moreLast updated: 11 days ago
    • Promoted
    Mental Health Therapist

    Mental Health Therapist

    SonderMind CareersLevittown, PA, US
    Full-time
    SonderMind is a leading mental health care platform revolutionizing therapy services by empowering licensed mental health therapists to deliver exceptional care with cutting-edge, AI-powered tools....Show moreLast updated: 4 days ago
    • Promoted
    Senior Director PBPK Consultancy

    Senior Director PBPK Consultancy

    Certara USA, Inc.Wayne, PA, United States
    Full-time
    Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharma...Show moreLast updated: 30+ days ago
    Senior Clinical Compliance Specialist

    Senior Clinical Compliance Specialist

    Innova SolutionsPhiladelphia,Pennsylvania,United States
    Full-time
    Quick Apply
    Innova Solutions has a client that is immediately hiring for.Senior Clinical Compliance Specialist.Position type : Full-time - Contract to hire. As Senior Clinical Compliance Specialist, you will be : ...Show moreLast updated: 30+ days ago
    • Promoted
    Licensed Marriage and Family Therapist in Multiple Philadelphia Clinics

    Licensed Marriage and Family Therapist in Multiple Philadelphia Clinics

    LifeStance HealthChesterfield, NJ, US
    Full-time
    We are actively looking to hire talented therapists in the area, who are passionate about patient care and committed to clinical excellence. Wanting to deliver high quality behavioral healthcare.Int...Show moreLast updated: 30+ days ago
    • Promoted
    Behavioral Health Consultant LCSW, LPC Needed in Pennsylvania

    Behavioral Health Consultant LCSW, LPC Needed in Pennsylvania

    CHG HealthcarePhiladelphia, PA, US
    Full-time
    Some physicians choose to live in the city for the ease and convenience, but Philadelphia's suburbs do not lack entertainment opportunities. Some of the best restaurants are located just a few minut...Show moreLast updated: 5 days ago
    • Promoted
    Chief of Oncologic Quality

    Chief of Oncologic Quality

    RWJBarnabas HealthNone, NJ, US
    Full-time
    RWJBarnabas Health is seeking an experienced and dedicated.This physician leader will oversee, plan, and execute strategies to elevate patient outcomes, safety, and satisfaction while meeting natio...Show moreLast updated: 3 days ago
    • Promoted
    Clinical Territory Associate

    Clinical Territory Associate

    Intuitive SurgicalAllentown, Pennsylvania, US
    Full-time
    Company Description At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potent...Show moreLast updated: 30+ days ago
    • Promoted
    Contracts Compliance Manager

    Contracts Compliance Manager

    firstPRO, IncBordentown, NJ, US
    Full-time
    Contracts Compliance Manager, Bordentown, NJ (Onsite), $130,000–$175,000 + Bonus – FULL-TIME.This newly created role offers hands-on exposure to senior leadership and the opportunity to...Show moreLast updated: 5 days ago
    • Promoted
    Travel Licensed Professional Clinical Counselor (LPCC) in Norristown, PA

    Travel Licensed Professional Clinical Counselor (LPCC) in Norristown, PA

    AlliedTravelCareersAllentown, Pennsylvania, US
    Full-time
    AlliedTravelCareers is working with TechLink Systems, Inc.LPCC in Norristown, Pennsylvania, 19408!.Job Title : Healthcare - Addictions Counselor. Location (On-site, Remote, or Hybrid?) : Norristown, ...Show moreLast updated: 3 days ago
    • Promoted
    Senior PBPK Consultant

    Senior PBPK Consultant

    Certara USA, Inc.Wayne, PA, United States
    Full-time
    Certara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharm...Show moreLast updated: 17 days ago
    • Promoted
    Data Science Associate Director

    Data Science Associate Director

    BioPharm Communications LLCNew Hope, PA, US
    Temporary
    Data Science Associate Director (BioPharm Communications LLC, New Hope, PA) Conduct research, build prototypes and drive production of new analytical product offerings. Execute ad-hoc analysis in a ...Show moreLast updated: 12 days ago
    • Promoted
    RN Clinical Educator - LTC

    RN Clinical Educator - LTC

    Good Shepherd RehabilitationBethlehem, PA, US
    Full-time
    To learn more text "RN - Good Shepherd" to 484-894-1659.Good Shepherd Home – Bethlehem is for individuals 18 years of age and older requiring residential nursing care.Primary diagnoses se...Show moreLast updated: 30+ days ago