The Manager, GxP Documentation and Training will be a key role within the Corporate Quality organization. You will be responsible for the Corporate Quality training program, ensuring alignment with compliance requirements and business strategy, including the day-to-day activities supporting the Learning Management System (LMS). In addition to serving as a subject matter expert in these areas, you will be responsible for maintaining strong, collaborative partnerships with cross-functional/cross-site team members to facilitate and manage a strategy that allows the corporate quality system to scale and align with the business drivers.
We’re looking for someone that understands “phase appropriate”, isn’t afraid to take risks, and will roll-up their sleeves and get a little dirty. This role is expected to embrace Rubius’s values; we are inventive, we have integrity, we are inclusive, we have courage, and we work with urgency. Diversity of thoughts, experiences, and backgrounds make us stronger, so ability to listen, debate and collaborate is a must. And last, but not least, we insist on having fun on this journey.
Lead the development and implementation of a training program to ensure that our learning and development strategy is aligned with the needs of the business.
Design, develop, deliver, and measure the effectiveness of training across the organization.
Conduct training needs assessments to ensure training is provided to the proper personnel per business needs and compliance requirements.
Develop and continually evaluate the content and process of the new hire onboarding experience.
Partner with internal groups to support the rollout of key training initiatives.
Create training materials including web-based training presentations and other supplemental training content.
Delivers training content to a diverse audience in an engaging and thought-provoking fashion.
Improve business processes and training documentation.
Lead administrator of the Learning Management System to include curriculum creation & modification; training assignments, class creation, scheduling, managing participation; reporting & technical support.
Monitor/Audit learning system data and information.
Drive learning process and system compliance/efficiency improvements.
Support the creation and development of course content and quizzes, focused on knowledge retention.
Manage system changes, including validation-related activities.
Qualifications & Education:
Bachelors or Advanced degree in Life Sciences or related field.
A minimum of 6 years of progressively responsible experience within the pharmaceutical/biotechnology industry with at least 2 years of Learning Management System (LMS) experience preferred (ComplianceWire experience a plus).
Work experience in a regulated environment (GCP, GLP, GMP).
Strong problem solving, project management, time management, organization, and prioritization skills.
Ability to work independently in a fast-paced environment and manage multiple priorities concurrently with minimal supervision.
Excellent written and verbal communication skills and proficiency in Microsoft software applications including Word, Excel, Visio, PowerPoint, Outlook, and SharePoint.
Internal Number: 1343
About Rubius Therapeutics
Rubius Therapeutics is a clinical-stage biopharmaceutical company developing a new class of medicines called Red Cell Therapeutics™. Our proprietary RED PLATFORM® was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and off-the-shelf allogeneic cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Our therapies can potentially be used to kill tumors in cancer and to regulate the immune system for the treatment of autoimmune diseases. We are currently enrolling patients in a Phase 1/2 clinical trial of RTX-240 in patients with relapsed/refractory or locally advanced solid tumors. In addition, RTX-240 is being evaluated in a second Phase 1 arm of the clinical trial for the treatment of patients with relapsed/refractory acute myeloid leukemia, and our IND has been cleared by the U.S. FDA for RTX-321 for the treatment of human papillomavirus 16-positive cancers.
We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2013, we are headquartered in Cambridge, MA, and our... manufacturing facility in Smithfield, RI was named 2020 Top 5 Best Places to Work in Rhode Island among medium-sized companies by Providence Business News. We are currently expanding across all functions within the organization. Red blood cells are no longer just for carrying oxygen. Check us out at www.rubiustx.com, or follow us on Twitter and LinkedIn or like us on Facebook.