Senior Manager, GMP Inspection Readiness

Job Description

GENERAL/POSITION SUMMARY:

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.

Key Duties and Responsibilities:

GMP Inspection Readiness

• Drive real-time GMP inspection readiness across Vertexs 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.

Inspection Planning Execution and Support

• 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.

Risk Management and Quality Oversight

• 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.

CMO Partnership and Cross-Functional Collaboration

• 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.

Continuous Improvement and Operational Support

• 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.

Required Education Level:

• Masters degree and 3 4 years of relevant work experience or Bachelors degree in a scientific or allied health field and 5 years of relevant work experience or relevant comparable background

Required Knowledge/Skills:

• 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.

Preferred Qualifications

• 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.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at