Senior Manager, GMP Inspection Readiness

Vertex Inc.•Boston, MA

11d•Hybrid

About The Position

The Senior Manager, GMP Inspection Readiness plays a key role in ensuring ongoing inspection readiness across Vertex and our manufacturing network. This individual will lead and enhance real-time GMP inspection readiness activities for Contract Manufacturing Organizations (CMOs) spanning multiple modalities, including Small Molecule, Cell & Gene Therapies, Biologics, and Medical Devices. Responsibilities include developing and managing readiness plans, overseeing key deliverables and metrics, identifying and mitigating risks, and supporting regulatory inspections from the preparation stage through follow-up activities. This role requires strong project management, strategic thinking, and the ability to work effectively across a broad range of stakeholders in a fast-paced environment. As a recognized subject matter expert in GMP quality, compliance, and quality systems, the Senior Manager will partner closely with internal teams and external manufacturing organizations to help maintain a continuous state of readiness, support global expansion initiatives, and drive continuous improvement of inspection readiness tools, processes, and programs.

Requirements

Demonstrated ability to drive results with urgency and operate effectively in a fast-paced, dynamic environment.
Strong project management and execution skills, including the ability to lead complex, cross-functional initiatives; develop and manage project plans, timelines, metrics, and dashboards; and ensure timely completion of key deliverables.
Strong analytical, strategic thinking, and problem-solving skills, with the ability to assess risk, identify gaps, and implement practical, compliant solutions.
Effective cross-functional collaboration and stakeholder management skills, with the ability to build trusted partnerships, align priorities, and drive results across internal teams and external manufacturing partners.
Excellent written, verbal, presentation, and facilitation skills, including the ability to tailor communications to different audiences and provide clear updates in real time.
Broad knowledge of GxP requirements across product lifecycles, with strong working knowledge of GMP regulations and their application in manufacturing and testing environments.
Demonstrated knowledge and practical application of: Quality risk management principles, Root cause analysis tools and methodologies, CAPA development and tracking, Quality systems, Audit and inspection processes.
Experience supporting regulatory inspections and inspection readiness activities, including planning, preparation of inspection materials, coordination of logistics, and support for inspection observations and follow-up actions.
Ability to interpret and apply applicable regulations, guidelines, and industry standards such as GMPs, ICH, USP, and other relevant guidance and best practices.
Experience authoring, revising, and maintaining SOPs and other controlled documents.
Proficiency with project management and tracking tools to monitor readiness status, maintain documentation, identify trends, and support continuous improvement.

Nice To Haves

Experience in Operational Quality Assurance within an analytical, manufacturing, and/or external manufacturing/CMO environment.
Experience supporting pre-approval and post-approval inspection readiness and ongoing compliance monitoring across CMO networks.
Experience with one or more product modalities, including small molecules, biologics, cell and gene therapies, and/or medical devices.
Experience working in a global, multi-site, or complex supply network environment.

Responsibilities

Drive real-time GMP inspection readiness across Vertex’s Contract Manufacturing Organization (CMO) network, supporting multiple modalities including small molecule, biologics, cell and gene therapies, and medical devices.
Develop, implement, and continuously enhance inspection readiness plans aligned with regulatory filings, site activities, and evolving business needs.
Drive the ongoing maturity of the inspection readiness program by strengthening tools, processes, governance, and execution standards.
Use project management tools and disciplined execution practices to ensure readiness activities are progressed efficiently, tracked effectively, and delivered on time.
Create and manage detailed project plans, timelines, metrics, and dashboards to monitor CMO readiness status and highlight key priorities.
Prepare and maintain critical inspection materials, including evidence binders, opening presentations, SME lists, and inspection storyboards.
Support regulatory inspections from preparation through follow-up action, including coordination of readiness activities, inspection logistics (including onsite sponsor support as required), and providing observation response-related support (draft review, CAPA tracking, etc.).
Maintain inspection-related history and documentation to support inspection trending, planning, continuity, and organizational learning.
Support inspection forecasting and the development, maintenance, and optimization of tools used to sustain inspection readiness.
Partner with internal and external stakeholders to identify, assess, communicate, and mitigate inspection risks in a proactive and timely manner.
Perform routine Quality System checks to confirm and sustain an ongoing state of readiness across the network.
Support global expansion activities by providing inspection readiness input and applying relevant regulatory intelligence to emerging needs.
Partner closely with CMOs and cross-functional teams to align on inspection readiness priorities, expectations, and deliverables.
Monitor CMO readiness pre- and post-approval to help ensure continued compliance and a sustained state of inspection readiness.
Serve as a trusted cross-functional partner by offering expertise, direction, and practical support to stakeholders across Quality and the broader organization.
Identify opportunities to improve processes, systems, and procedures, and actively contribute to continuous quality improvement initiatives.
Author, revise, and maintain Standard Operating Procedures (SOPs) and other controlled documents, as needed.
Provide broader support to the CMC Compliance Team, including support for internal GMP inspections, as needed.
Lead or contribute to additional projects and initiatives, providing project management support and oversight where appropriate.