The Process Facilitator, as part of the Quality Assurance Organization, is responsible for process management, including documentation and training, across the Clinical and Regulatory functions at Vertex. This individual will have responsibility for design and execution of processes, documents and training, conducted both internal to Vertex and at their respective vendors, in assuring adherence to applicable regulations, industry standards, and to Vertex policies, procedures and quality standards as set forth in the Quality Management System. This individual will manage and execute activities to develop and improve processes, documents and training to drive continual improvement across the clinical and regulatory functions.
In this position, you will be an integral contributor to Vertex’s continuous improvement efforts, by championing organizational process and system excellence. In this dynamic and highly visible role you will also be extensively interfacing with both internal and external stakeholders to position Vertex for continued future success.
The ideal candidate is someone with experience in pharmaceutical clinical operations, document management, training and continuous improvement and who thrives in an environment with an ability to shape an evolving document and training program in support of this expanding team.
Position may require up to 10% national/international travel.
- Design, develop, and maintain technical content deliverables in many formats to best meet users' needs, including video tutorials to explain complex information
- Act as a liaison with business departments to implement process improvement.
- Gather information and seeking out and identifying opportunities, and business process definition by defining and documenting processes and procedures.
- Identify problem or process, researches alternatives, contributes to presentations, tests to confirm, and participates in implementing solutions for defined business processes.
- Create and document business processes, training procedures, and standard operating procedures
- Master’s (or equivalent degree) and 2 years of relevant work experience, or
- Bachelor’s degree and 6 years of relevant work experience, or
- Relevant comparable background and 10 years of relevant experience.
- Work experience is in knowledge management or process improvement in the pharmaceutical, medical device or related healthcare industry.
- Prior experience in GCP, GLP or GVP operations
In-depth knowledge in the following areas:
- Quality regulations and guidance (for example ISO, FDA regulations, EU Directives, ICH guidelines; and other industry standards).
- Quality Management System Documentation and Training best practices
- Process management and Knowledge management techniques
- Lean Six Sigma Black Belt or equivalent experience
- Relevant scientific education and knowledge to provide quality assurance oversight for quality activities, understand specific activities including technical writing, training development and deployment, and continual process improvement methodologies including root cause analysis, and appropriate methodologies (e.g. Lean, Six Sigma, etc)
- Risk management principles and process
- Change management
- Communications: professional, clear, concise and consistent both verbally and in writing to internal and external customers.
- Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.
- Must be able to work independently and in a collaborative team setting.