Rubius is seeking to add a new “Ruby” to the Quality Organization as a Manager of Quality Systems. Our team members work collaboratively and are motivated self-starters who deliver exceptional work. Do you thrive on working on the cutting edge? Working with innovators in the early stages of ideas, products, or platforms? Do you want to transform patient lives? You would be responsible to support and enhance the QMS (Quality Management Systems) programs related to key compliance initiatives, applicable regulatory requirements, and in accordance with company policies, site procedures, industry guidance and health authority regulations. You will also work directly with the Quality Systems team to ensure document management, training, CAPA, change control and archival processes are being executed according to procedure and Rubius business practices. You will help manage and support the data for Quality Management Review and prepare metrics as required. You have the ability to partner cross-functionally and cross-site while maintaining our high standards of compliance. You love to communicate, are obsessive about the details, and know how to have fun on this journey.
Manage and assists with Quality System record management (Change Control, Deviation, CAPA and Effectiveness Checks) both paper and electronic.
Act as a Quality Contact for change controls by reviewing, approving and managing changes from inception to close.
Oversight of all Quality System records to ensure on-time closure and adherence to KPI’s.
Prepare data/metrics as required to support QMR Quality Management Review, KPI’s and training.
Contribute to the management of curricula maintenance and training assessments.
Deliver training on Quality System related functions.
Participate in the document creation and revision process through project timelines using electronic systems. Documents may include SOP’s, product specifications, master batch records and forms.
Support records management activities such as the archival submission process, retrieval, and retention of records.
Qualifications & Education:
BS/BA degree in Chemistry, Biology, or related field
Minimum of 6 years of progressively responsible experience within the in biopharmaceutical/ pharmaceutical industry with 3-4 years direct Quality Systems experience.
Experience with Veeva electronic document management system is desired.
Ability to independently prioritize daily activities to meet internal and external customer needs in a fast-paced environment.
Experience in both paper based and/Quality Management Systems (QMS) is desired
Thorough knowledge of cGMPs, GCP, EU/ICH and global regulatory requirements.
Experience in quality systems design and implementation required.
Excellent written and verbal communication skills and proficiency in Microsoft software applications including Word, Excel, Visio, PowerPoint, Outlook, and SharePoint.
Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals.
Team-oriented approach to project management and problem resolution.
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.