GxP Process Facilitator, Manager

  • Contract Duration: Through 2021, Remote
  • Clinical
  • Boston, MA

Website Lenox Executive Search

Job description

Lenox Executive Search is seeking a GxP Process Facilitator, Manager working REMOTE. This is a contract role, that will last through 2021, with one of our global pharmaceutical clients.

GxP Process Facilitator, Manager

The GxP Process FacilitatorManager as part of the Quality Assurance Organization, is responsible for process management, including documentation and training, across the Clinical and Regulatory functions. This individual will have responsibility for design and execution of processes, documents and training, conducted both internal and at their respective vendors, in assuring adherence to applicable regulations, industry standards, and to Company 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.

Key Responsibilities of a GxP Process Facilitator, Manager:

  • 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

Minimum qualifications of a GxP Process Facilitator, Manager :

  • 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

GxP Process Facilitator, Manager MUST HAVE 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.
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Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team