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Job Description

The Associate Director, GDP Inspection Readiness is recognized as an expert in the principles and application of quality and regulatory compliance. The Associate Director, GDP Inspection Readiness adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. This role is responsible for development and oversight of internal GDP inspection readiness plans for all of Vertex’s affiliate sites, including the management and identification of risks and tracking of metrics, as well as providing inspection support and regulatory intelligence assessments for global expansion markets. This role requires partnering with various internal and external cross-functional teams including: Vertex affiliate sites/ RPs, vendors, Contract Manufacturing Organizations, Supply Chain, and others within Vertex Quality Assurance. This role requires strong knowledge of GDP principles to drive inspection readiness in close collaboration with the local RPs.

This position reports to Director, Small Molecule CMC Compliance.

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

• Real-time GDP Inspection Readiness;
  • Manage global real-time GDP inspection readiness plans for the Vertex affiliate sites , vendors and expansion markets
  • Develop, manage and provide oversight for ongoing maturity of GDP Inspection Readiness Plans associated with regulatory filings and real-time inspection readiness activities
    • Work with internal teams on key issues/potential risks to ensure inspection readiness
    • Develop project management plans with key metrics
    • Provide PM oversight of readiness activities, including the build-out and maintenance of dashboards
    • Support development and oversight of mitigation plans
    • Identify and communicate risks
    • Utilize tools and project management skills to ensure efficiency in execution
    • Coordinate with Vertex affiliate sites, Vendor Quality Management (VQM), Audit/Inspection Management (AIM) and Function Area Quality reps on any key issues to ensure readiness of Vertex affiliate sites
  • Communicate inspection risks to Steering Committees / Sr. Management.
  • Perform gap assessments associated with regulatory intelligence, global expansion, inspection outcomes and inspection related themes to ensure compliance across Vertex sites and suppliers
  • Develop strategy and lead efforts to shift from heavy reliance on inspection readiness plans to maintaining and operating in an inspection ready state
  • Develop process for review of key elements for inspection readiness and complete reviews of quality data to ensure continued state of readiness
  • Present monthly GDP metrics to leadership and highlight potential risks in the inspection readiness dashboard
  • Provide guidance and drive results for colleagues accountable for GDP Inspection Readiness activities

• Provide inspection support in collaboration with the Audit/Inspection Management team;
  • Coordinate with regional QA leads on global inspections
  • Attend program meetings and ensure oversight of inspection readiness of CMOs that will be included in submissions
  • Collaborate with BSMO Project Management team and QA submission auditor to ensure source documents are identified to support inspections; ensure risks to timing of critical inspection elements are identified and communicated/ escalated
  • Provide GDP inputs for inspection forecast and support maintaining repository for country-specific GDP requirements
  • Maintain Inspection opening presentations, SME lists and support development of storyboards.
  • Support process for and review/updates to affiliate quality handbooks
  • Provide support for inspection responses and process for feedback loop of key issues to inspection readiness plans

• Support for managing vendor GMP Certifications and Declarations to support for Regulatory submission activities
• Support process for and manage plans associated with regulatory intelligence for expansion into new regions and countries
• Other responsibilities may include support to GMP inspections of Vertex facilities or CMOs

Key Requirements:

• Relevant Degree in a scientific or allied health field
• Strong experience in Inspection Readiness within Pharma/ Biotech
• Experience with small molecules, biologics, devices or gene therapy
• Strong leadership skills with the ability to thrive in a fast-paced environment
• Critical, Analytical and Strategic thinking skills
• Ability to lead and manage complex projects/teams within corporate objectives and project timelines
• Ability to drive results, work collectively with stakeholders and maintain composure under pressure
• Ability to communicate effectively across all organizational levels
• Broad GxP Knowledge and understanding across lifecycle of the product
• Knowledge and application of:
  • GDP principles and RP oversight expectations
  • GMP and GDP regulations and application to Manufacturing, Distribution and Testing risk management principles
  • Root Cause Analysis tools/methodology and CAPA
  • Audit process.

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