Validation Director at Vertex in Boston, MA

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Job Description:

The Validation Director will own the strategic vision for all Validation programs at the Vertex Manufacturing Site. They are responsible for oversight of the validation team, technical development of personnel and ensuring the quality of deliverables within their purview. The Validation Director is recognized for their technical expertise both within and outside of the organization. They integrates activities of the group with those of other Groups, Departments and Project teams, as needed. Aligns team goals with organizational goals, as well as projects/activities and refining those projects and/or activities proactively.

Key Responsibilities:
  • Provide Validation oversight to support cGMP systems / programs in accordance with cGMP regulations and Vertex standard practices
  • Partner with DPF, Technical Operations, Formulation Development, GMP Quality, GIS and other groups as needed to provide validation activities in support of GMP work at the Vertex Manufacturing Center (VMC)
  • Lead validation teams with responsibility for defining strategy, coordination, planning, & execution of validation activities
  • Partner with project managers to determine project priorities, track progress, and provide regular project status updates
  • Provide oversight to project contractors to ensure compliance and validation requirements are met
  • Provide support to audits as needed to assess software development life cycle (SDLC) and equipment engineering methodologies at Suppliers providing manufacturing equipment and control systems
  • As needed, manage qualification activities and participate in decisions to support implementation of continuous processing equipment at Vertex and CMO sites
  • Support and provide input to process improvement initiatives involving validation and cGMP controls used to maintain the validated state of systems
  • Tunes Group activities to company priorities and adapts resources as needed, to ensure key goals are met on time
  • Helps craft personnel goal setting to best align with corporate and department goals
  • Builds cross-functional networks and effectively influences key stakeholders to advance department and corporate objectives
  • Determines project assignments and staffing requirements for projects
  • Motivates staff and resolves conflicts
  • Stay current with applicable regulations and industry practices. Provide updates to business areas and update procedures and practices accordingly to align with current regulations and industry standards
  • Demonstrates strong aptitude helping to lead a group or team endeavor and building team unity
  • Communicates clearly and concisely (reading/writing and verbal) with across levels of the company
  • Displays strong commitment to the company's core values
  • Able to perform complex assessments for automated processing systems against current industry compliance requirements
  • Advanced understanding of 21 CFR Part 11, cGMP, and other regulatory guidance for manufacturing equipment and automated processing systems
  • Must be able to establish strong working relationships with stakeholders (Quality, DPF, Tech Ops, and GIS) to ensure high quality deliverables meeting cGMP and Vertex validation requirements
  • Demonstrable team leadership, problem solving, creative and critical thinking and project planning skills
  • Thorough knowledge of and high competence in core quality systems such as change control, deviations, investigations, CAPA management and document control
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Qualification:

  • Bachelor's or Master's Degree in Engineering or related field
  • 10 plus years of progressive experience in Validation and people management within the pharmaceutical industry
  • Expert knowledge of validation and system implementations in a GMP manufacturing environment
  • Small molecule or continuous manufacturing experience preferred

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