Kopsy Advisory Network

Kopse Advisory Group is building a curated network of senior life sciences professionals who bring deep, real-world expertise in quality, regulatory, manufacturing, and risk.

Our selected network of advisors understand what is required when the stakes are high and consistently support client work that demands specialized experience, independent judgment, and practical fluency in regulated environments.

We selectively engage senior life sciences professionals with deep expertise in quality systems, regulatory affairs, manufacturing, and enterprise risk management to support client-facing advisory work on a project basis.

  • We are looking to connect with experienced professionals who have held leadership or senior technical roles in areas such as:

    • Quality Systems & Quality Assurance (GxP environments)

    • Enterprise Quality Risk Management (ICH Q9 / Q9(R1))

    • Regulatory Affairs (global submissions, agency interaction)

    • Cell & Gene Therapy / Advanced Therapeutics

    • GMP Manufacturing & Tech Transfer Validation Strategy (CSV / CSA, digital quality systems)

    • Supplier Quality & Audit Programs

    • Clinical Quality & Compliance Systems

    • Data Integrity & Digital Transformation in regulated environments

  • Kopse Network members are not employees or general contractors. They are trusted collaborators who may be invited into engagements based on:

    • Domain expertise relevant to client needs

    • Depth of industry experience

    • Availability and interest in specific projects

    • Alignment with Kopse Advisory Group’s standards of rigor and professionalism

  • Engagements are typically:

    • Project-based or advisory in nature

    • Senior-level, decision-support focused

    • Scoped to high-impact quality and regulatory challenges

  • We prioritize professionals who:

    • Have led, not just supported, regulated quality or compliance systems

    • Operate with calm precision in high-pressure environments

    • Understand both regulatory expectations and operational realities

    • Can translate complexity into actionable decisions

    • Are trusted voices within their domain

Join our Network

If you would like to be considered for the network, please use the form to share a brief overview of your background, core areas of expertise, and the types of engagements you are best suited for.

Kindly include any relevant leadership experience in regulated environments.

All submissions are reviewed for alignment with current and future advisory needs. If there is a fit, we will reach out to schedule a brief introductory conversation.

We appreciate your interest in contributing to Kopse Advisory Group’s network of senior practitioners.