Executive Director/VP, Quality Assurance
Urovant Sciences, Inc. is a 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, GEMTESA® (vibegron), is an oral, once-daily (75 mg) small molecule beta-3 agonist approved by the U.S. FDA in December 2020 for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. GEMTESA® is also being evaluated for the treatment of OAB in men with benign prostatic hyperplasia (OAB+BPH).
Urovant's second product candidate, URO-902, is a novel gene therapy being developed for patients with OAB who have failed oral pharmacologic therapy.
The Executive Director/VP of Quality, within Urovant's Regulatory Affairs and Quality organization, is responsible for development, implementation, and management of Urovant's quality systems for R&D.
Key Duties and Responsibilities
- Develop, implement, and manage Urovant's R&D quality systems and operations to best ensure compliance of the company's prescription therapeutic development activities with applicable global health authority regulations and guidance (e.g. US FDA, EMA, ICH, etc.), including GCP, GMP, GVP, GLP and CSV.
- Oversee document control, deviation management, investigations, CAPA, change control, supplier quality oversight, audit, training and compliance programs. and operations to ensure compliance with GCP, GVP, GMP, GLP and CSV.
- Responsible for release of product to market and clinical sites.
- Develop and maintain complement of documentation supporting quality system
- Oversee the implementation, validation and maintenance of GxP Software
- Manage audit program including CRO (clinical and nonclinical) and CMO qualification audits, internal and external database (e.g. clinical study and safety) audits, and key deliverable/study component (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE) audits and internal audits as appropriate.
- Provide leadership and support of health authority inspections (e.g. GCP, GMP), including preparation for, coordination of, and driving appropriate follow-up/close out activities (e.g. CAPA).
- Effectively interface with colleagues in CMC/Technical operations, Clinical, R&D, IT and business partners to assure compliance with all relevant regulations and Urovant procedures
- The Executive Director of Quality will remain current with related quality legislation and compliance issues, and serve as an internal subject matter expert for changes in GxP expectations (including FDA, EMA, and other relevant global health authorities), guidance documents and best industry practice.
- Develop and measure quality-focused metrics to drive consistent standards and to facilitate regular updates to senior leadership regarding company compliance status.
Education and Experience
Bachelor's degree; advanced/graduate degree preferred.
At least 12 years' experience in Quality or Quality related roles
Essential Skills and Abilities
Ability to work in a team environment
Successful track record of working in a matrixed organization and building positive and effective relationships with other functions and contractors/vendors
Excellent interpersonal, reading, writing, and presentation skills
Ability to identify and manage contract/vendor resources to support Quality-related goals
Ability to work on several projects and assignments at the same time and to prioritize deliverables
Ability to work across locations and time zones
Strong financial business acumen and analytical skills
Ability to develop and manage expenditures in accordance with budget
A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect
To ensure the health and safety of our workforce while doing our part to protect those around us, Urovant Sciences is requiring proof of full COVID vaccination for US and Global employees as a condition of employment to the extent permissible under federal and state laws and subject to legally-recognized accommodations.