Job Description

Vertex Pharmaceuticals

Quality Assurance

Position Description

Title/Role:Senior Manager, GMP Inspection Readiness /Small Molecule CMC Compliance

AREA: Inspection Readiness

GENERAL/POSITION SUMMARY:

The Senior Manager of GMP Inspection Readiness role is responsible for managing real time inspection readiness activities supporting GMP 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 cross-functional teams including Contract Manufacturing Organizations (CMOs), Vertex Manufacturing Center, Technical Operations, Supply Chain and others within Quality Assurance.

Key Duties and Responsibilities: The responsibilities of this role may include, but are not limited to, the following:

• Real-time Inspection Readiness
  • Develop, manage and contribute to ongoing maturity of GMP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities
    • 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 cross-functional support and guidance to stakeholders
  • Support CMO inspection readiness plans and support management of CMO inspections and responses
  • Monitor inspection readiness of CMOs post-approval to ensure continued inspection readiness state
  • 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; including supporting GDP inspections globally, as needed
  • Author/Revise Standard Operating Procedures
  • Lead and assist with additional projects and provide project management support/oversight as needed

Required Education Level:

• Master's degree and 3 - 4 years of relevant work experience, or Bachelor's degree in a scientific or allied health field and 5+ years of relevant work experience, or relevant comparable background

Required Knowledge/Skills:

• Results driver who operates with a sense of urgency and can navigate a fast-paced environment
• Strong analytical and strategic thinking skills
• Project Management / Continuous Improvement
  • Ability to lead and manage complex projects/teams within corporate objectives and project timelines

• Proficiency utilizing project management processes / tools to lead meetings, project planning and facilitating completion key deliverables

• Cross-functional Collaboration
  • Ability to drive results, work collectively with stakeholders and maintain composure under pressure
• Communication/ Influencing
  • Ability to communicate effectively across all organizational levels
  • Presentation/Facilitation skills-ability to adjust presentation to audience and information real-time
  • Ability to effectively influence others within technical area of expertise
• Broad GxP Knowledge and understanding across lifecycle of the product
• Knowledge and application of:
  • GMP regulations and application to Manufacturing and Testing risk management principles
  • Root Cause Analysis tools/methodology and CAPA
  • Audit process

• Operational QA experience in analytical or manufacturing setting with experience with the following is preferred:
  • Inspection support roles
  • Quality System background
  • Interpretation and application of GMPs and applicable guidelines/ guidances (e.g., ICH, USP, etc.) or other industry best practices (e.g., ISPE, WHO, etc.)
  • Experience with small molecules.
  • Experience with biologics, devices, gene therapy a plus.

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

• Hybrid: work remotely up to two days per week; or select
• On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-AR1

Company Information