Associate Director, Quality Systems and Documentation

We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.

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.
  
  

Read more about our pipeline and visit us on LinkedIn

Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:

• Highly competitive and inclusive medical, dental and vision coverage options (US & UK)
• Flexible Spending Accounts for medical expenses and dependent care expenses (US)
• Flexible Vacation Plan (US & UK)-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission.
• Care.com Memberships (US)
• Education Assistance Program (US & UK)
• 401k match (US) and Financial Planning tools, Private Pension (UK)
• Employee Stock Purchase Plans (US &UK)
• Employee Assistance Program (US &UK)
• Reward & Recognition Program (US & UK)
• Catered Lunch (site dependent)
• Onsite Yoga (UK)
• Free Parking (US & UK)
  
  

Our core values

The way we work sets Agenus apart.

We put the patient first.

We aspire to change the world, improving the experience and options available for every single cancer patient. The answers are out there, and patients are waiting.

We are bold, and we are one.

We believe that the only way to deliver on our goals is to aim high and work as one global team. We look for opportunities to challenge, collaborate with, and support one another. We aim to break conventional standards and perform at extraordinary levels.

We work with integrity, respect and honesty.

These three building blocks serve as pillars for how we behave, operate, and execute our mission.

We are a culture of ownership and accountability.

We hold ourselves accountable not only for exceptional results, but how we get our results.

We are obsessively curious and deeply committed to learning.

We live in a fast-paced environment that requires us to learn at or above the speed of change. We believe that curiosity fuels the desire to create, and learning provides the tools to progress.

We perform at our best every day.

Every day counts. We confront insurmountable obstacles, problems and choices with intellect, perseverance and hard work.