Logo
RPMGlobal

Associate Director, Quality Systems and Documentation

RPMGlobal, New York, New York, United States,


The Role:

The Associate Director (AD), Quality Systems and Documentation will maintain and continually improve the global Agenus electronic Quality Management System (eQMS) platform and enable compliant electronic and paper-based document control and archiving for the Agenus Enterprise Quality Management System (QMS). The AD, Quality Systems and Documentation will work to ensure seamless execution of current eQMS platform, future enhancements and system integrations supporting the lifecycle management of applicable regulated quality systems, processes, and documentation.

The AD, Quality Systems and Documentation will manage, configure, and implement changes to eQMS, and ensure execution of Global Quality Systems controlled document processes. This responsibility includes management of all technical aspects of the eQMS software; system administration, configuration enhancements for process improvements, QMS quality metrics, analysis, and reporting; as well as creating and delivering eQMS user-support procedures and system training.

The successful candidate must have deep understanding of eQMS software development life cycle (SDLC) in a regulated environment (i.e., cGMP, GCP, GLP) with strong project management and business process analysis skills, and direct experience managing Document Control in a regulated environment.

In the role you will:

Technical development and implementation of a scalable global electronic Quality Management System (eQMS). Support strategy development, across the organization, design, develop, and deliver all eQMS modules, including system implementation, project management, user acceptance testing, and training.

Responsible for the lifecycle management; from design, release and change control of updates/upgrades through retirement of the Agenus eQMS software application(s) through collaboration with internal, external, Quality Validation & Engineering (QVE) and functional area stakeholders.

Responsible to lead and drive harmonization of eQMS initiatives and overall routine management of the systems to advance global initiatives, such as eQMS workflow improvements to increase efficiency and address applicable usage for all phases of product development lifecycle.

eQMS user support, including development of training content, documentation, and delivery of training sessions, to empower users to operate independently and effectively. Create/Maintain SOPs and training related to Quality IT systems.

Track and measure effectiveness of eQMS system changes, ensuring appropriate introduction to employees via communication plans, training sessions, and other learning aids.

Establish Agenus Quality department metrics, analysis and reporting (MAR) functionality to support Agenus management, oversight and continuous process improvement.

Support the management, assignment, and maintenance of Training Curriculum (group of assignments) so that training is assigned as applicable to employees who have a responsibility or accountability within a regulated process; either just in time or in accordance with documented accountability/responsibility.

Support of inspection readiness initiatives and regulatory inspection activities.

Qualifications: About You

Bachelor’s degree required; scientific or IT emphasis preferred.

5+ years related experience in eQMS System Administration and Document Control management.

IT Project/Change Management experience from design to implementation, preferably in cGMP and GCP regulated environments.

Proficient experience with an electronic QMS and/or LMS software required. Experience in ZenQMS preferred.

Proficient with software lifecycle management, change control, and computer system validation activities.

Experience using software tools for creation of computer-based, e-learning content, such as Camtasia or Captivate, preferred.

Experience in Life Sciences (Biotech, Pharmaceuticals) industry including implementation of solutions with a focus on GMP, GCP and/or GLP compliance.

Experience with the development and implementation of QMS metrics, analysis and reporting.

Technical proficiency administrating eQMS software; ZenQMS preferred.

Document control management and oversight.

IT Project/Change Management experience.

Data metrics, analysis and reporting.

Outstanding communication skills (verbal and written).

Ability to navigate through ambiguity and rapid growth and adapt to change.

Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.

Authoring/development of training content using PowerPoint, audio/video applications, etc.

Expertise in validated systems ensuring successful delivery on projects from requirements to implementation. Experience in the regulated drug/biologics development and commercialization space preferred.

Ability to apply regulated requirements and current industry practices in the administration of the regulated training program and eQMS.

Proven ability to lead, manage and develop the Document Control (DC) functional area (FA) and DC staff.

Proven ability to lead, manage and develop projects/teams of significant scope and complexity, while meeting deliverables and timelines.

Demonstrated critical problem-solving skills with ability to coordinate process improvement initiatives and quality system related projects with broad scope and complexity.

Ability to interact effectively with all levels of personnel within the organization.

Proactive and independent leadership. Must be able to perform functions under minimum supervision. Receives general instructions on new work; refers to policies and practices for guidance.

Ability to balance short and long-term goals and to prioritize appropriately to support company goals.

Ability to evaluate continuous improvement actions, keeping abreast of relevant scientific, regulatory and business environments.

#J-18808-Ljbffr