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. Our IND for RTX-240, our first oncology candidate for the treatment of solid tumors, has been cleared by the FDA. Additionally, we plan to file an IND for RTX-321 for the treatment of HPV-positive tumors by year-end.
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 based in Cambridge, MA and 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
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As a key member of the Quality Team, the Quality Systems/Compliance Lead is responsible for leading and executing activities related to procedural document development and training with touch points across Rubius, as well as the management of selected contract manufacturing sites, raw material vendors and GxP service providers engaged in the production of Rubius products. Under limited supervision, this candidate must be able to communicate effectively to all levels internally with departments such as Purchasing, Product Development, Manufacturing, Supply Chain, other Quality functions, and Regulatory Affairs, as well as with Rubius’s vendors, in order to provide quality leadership. This individual should be able to work independently and operate in a fast-paced environment that embraces change and flexibility. This individual will also develop and implement Quality Systems procedures to enhance efficiency and compliance.
We’re looking for someone that understands “phase appropriate”, isn’t afraid to take risk, and will roll-up their sleeves and get a little dirty. This role 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.
Qualifications & Education
- Document Management support:
- Subject Matter Expert in the use of electronic document management system (Veeva), use of document templates and MS word formatting.
- Manage the documentation creation and revision process for SOPs and other regulated documents using electronic systems.
- Provide guidance and support to internal customers in creation and maintenance of departmental and corporate procedures.
- Collaborates with functional departments to ensure documents are reviewed/approved in a timely manner.
- Training support:
- Performs training in support of the document management system for users
- Maintains GxP training files
- Supports other quality systems as needed including deviation management, CAPA and change controls.
- Generates metrics related to quality system processes: document control, training, deviation management, CAPA, Change Controls, etc.
- Quality Compliance Responsibilities:
- Actively participate in the Vendor Management program
- Provide guidance in applying vendor quality system requirements
- Partner with vendors to establish relationships
- Develop and revise Quality Technical Agreements
- Manage vendor notification of changes to ensure impact is thoroughly assessed prior to implementation
- Aide in the establishment and maintenance of policies and procedures for the Vendor Management program
- Support to vendors including audits/assessments, CAPA and change management
- Lead additions/deletions/changes to the status of suppliers on the Approved Vendor List, including vendor master file records
- Supports other quality systems as needed, including deviation management, CAPA and change controls.
- Other tasks as appropriate to support product development in a regulated environment.
- Bachelor’s in Life Sciences or related field with 7+ yrs of experience, with at least 2 years in a QA environment.
- Thorough knowledge of quality systems, quality tools and methodologies.
- Experience in quality systems including but not limited to document control, records management, training, deviations management, change control, CAPA and vendor quality management.
- Work experience in regulated environment (GMP, GCP, GLP).
- Experience with Veeva, a must.
- Auditing background is preferred.
- Strong communication, teamwork, and problem-solving skills are required.
- Excellent organizational skills, attention to detail, written and verbal communication skills.
- Demonstrated success in collaborating with cross functional teams.
- Ability to Travel (occasionally).