Improving quality-of-life through innovations in urology.
Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions and improving the way providers and their patients confront urologic diseases that are difficult to treat.
Every employee at Urovant plays an integral role to our success. We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve. Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.
Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). In addition to OAB, vibegron is being evaluated for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).
Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Manager, Quality Assurance is responsible for contributing through development, implementation, and management of Urovant’s Quality Systems for R&D.
The position is based at Urovant’s site in Irvine, CA and reports to the Director of Quality.
- Manage SOP and regulated documentation systems and support the preparation and or review of new, revised SOP, test methods, and validation documents.
- Perform GMP Batch Release of clinical, validation, and commercial product.
- Support health authority inspections (GCP, GMP, GLP) and vendor qualification activities, including conducting or participating in supplier and internal audits.
- Administrator of, and primary contact for Urovant R&D’s CAPA program. Provide leadership in corrective action implementation and drive follow-up on audit issues until completion.
- Provide quality & regulatory technical guidance to internal R&D functions and external vendors (e.g. CRO, CMO).
- Contribute to development and maintenance of the Change Control and Product Quality complaints systems.
- Identify the need for investigations due to deviations from written procedures, review investigations into non-conformance incidents/deviations, and recommend disposition of the affected product/component.
- Develop and provide quality metrics and trend reports for functions and leadership.
- Perform quality and regulatory related training.
Education and Experience
- Bachelor’s degree; advanced/graduate degree preferred.
- 3+ years of experience in Quality or Quality-related roles in the Pharma/Medical Device industry
- Experience with internal audits and health authority inspections (GCP, GMP, GLP)
Essential Skills and Abilities
- Ability to work in a team environment
- Strong project management skills and ability to perform/prioritize multiple tasks in a fast-paced, deadline-driven environment with limited supervision
- High level interpersonal skills with the ability to influence others, internally and externally, in a positive and effective manner
- Excellent written and oral communication skills
- Highly proficient using Microsoft Word, Visio, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems
- Ability to prioritize tasks and work across locations and time zones
- Exceptional communication skills, both verbally and in writing
- A commitment to collaborative teamwork and the maintenance of a professional culture based on trust and mutual respect