Inspection Readiness Manager (Contract)

General position summary: This role is responsible for managing real time inspection readiness activities supporting GMP and GDP quality. The role requires the ability adapt to new and multiple projects effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. The role is responsible to provide technical expertise and project management of inspection readiness as well as provide support during inspections. This role is recognized as an expert in the principles and application of quality assurance and compliance and the role includes partnering with various internal and external crossfunctional teams including Contract Manufacturing Organizations Vertex Manufacturing Center Technical Operations Supply Chain and others within Quality Assurance.

This position reports to the Associate Director CMC Small Molecule Compliance

Key Responsibilities:

The position is responsible to ensure the successful execution but is not limited to the following:

• Realtime Inspection Readiness
  • Develop manage and contribute to ongoing maturity of GMP and GDP Inspection Readiness Plans associated with regulatory filings and realtime inspection readiness activities
    • Work directly with CMOs and the Vertex Manufacturing Center on inspection readiness activities including identification of potential inspection risks
    • Work with internal teams on key issues to ensure inspection readiness
    • Develop project management plans with key metrics
    • Provide PM oversight of readiness activities
    • Build and maintain dashboards
    • Contribute to ongoing maturity/growth of the inspection readiness program
  • Assist with developing and providing oversight of mitigation plans
  • Develop evidence binders for inspections
  • Support Global Expansion Activities as they relate to inspection readiness and regulatory intelligence
  • Perform routine Quality System checks to support readiness
  • Identify and communicate risks
  • Utilize tools and project management skills to ensure efficiency in execution
  • Assist in maintenance of opening presentation Site Master File SME list and development of storyboards
  • Support initiatives associated maintaining relevant inspection related history for inspection readiness purposes
  • Provide inspection support for affiliate inspections including storyboard simulation
  • Provide crossfunctional support and guidance to stakeholders
  • Provide additional support for CMO inspection readiness plans and support management of CMO inspections and responses
  • Support inspection forecasting and development/maintenance of tools used to support inspection readiness
• Small Molecule GMP Evidence to support GMP/GDP activities
  • Support incoming requests for Small Molecule GMP/GDP Certificates for vendors and Vertex sites
• Other Activities
  • identify areas of improvement and participate in process improvement initiatives
  • Additional as needed support to processes systems procedures to ensure continuous Quality improvement
  • Additional activities as needed to support the SM CMC Compliance Team
  • Author/Revise Standard Operating Procedures
  • Lead and assist with additional projects and provide project management support/oversight as needed

Minimum qualifications:

• 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
• Proficient at creating tools and processes for efficient execution
• Proficient in project management and utilization of PM tools
• Proficient communication skills to facilitate successful cross functional collaboration
• Results driver who operates with a sense of urgency and can navigate a fastpaced environment
• Organizational skills and ability to work both independently and crossfunctionally
• Critical Analytical and Strategic thinking Ability to assess impact across multiple procedures and systems
• Problem Solving skills
• Continuous Process Improvement Skills
• Knowledge and application of:
  • GMP/GDP regulations and application to Manufacturing and Testing risk management principles
  • Root Cause Analysis tools/methodology and CAPA

dependent upon experience.

This job posting is for a temporary role with a thirdparty agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the thirdparty agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other jobrelated factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements

By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employmentrelated information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively Atrium Alerts). Atrium Alerts may be sent by email phone or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time please contact Atrium at .

If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.

No C2C or ThirdParty Vendors