Improving quality-of-life through innovations in urology.
Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions.
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, is a β3-adrenergic agonist being developed for an oral, once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.
Urovant's second investigational product candidate, hMaxi-K, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Director of Quality will be responsible for the development, implementation and management of Urovant’s quality systems and operations ensuring compliance with GCP, GVP, GMP and GLP.
The position is based at Urovant’s site in Irvine, CA and reports to the Sr. Vice President of Regulatory Affairs and Quality.
- Establish and maintain appropriate GxP quality systems and operations covering deviation management, investigations, CAPA, change control and compliance programs
- Develop and maintain complement of documentation supporting quality system (e.g. quality manual and controlled documents)
- Establish and implement internal GxP compliance training programs; oversee training management and documentation
- Institute a comprehensive risk-based inspection readiness plan for regulatory authority inspections, focusing on the Sponsor oversight role with Contract Research Organizations (CRO) and Contract Manufacturing Organizations (CMO)
- Manage internal and CRO/CMO audits, working with audit vendors, maintaining audit logs and ensuring follow-up and satisfactory closure of audit findings
- 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)
- Oversee Urovant’s R&D controlled documents, regularly reviewing the full complement to ensure appropriate scope and detail and driving resolution of identified gaps
- Ensure appropriate Quality-focused review of clinical (e.g. protocols, study reports, IBs, ICFs, TMFs, etc.) and CMC (e.g. batch records, disposition of drug substance and drug product, release of clinical trial materials in IRT systems) documentation
- Conduct or participate in CRO (clinical and nonclinical) and CMO qualification audits, internal and external database (e.g. clinical study and safety) audits and key deliverables/study component (e.g. study process documents, TMFs, CSRs, tables, listings, ISS, ISE) audits, as appropriate
- Develop and measure quality metrics to drive consistent standards and to facilitate regular updates to senior leadership regarding company compliance status
- Remain current with related quality legislation, compliance issues and is an internal subject matter expert for changes in GxP expectations, including FDA, EMA and other relevant global health authorities, guidance documents, and best industry practices
- Identify and manage appropriate contractor/vendor resources providing support for Quality initiatives
- Manage relevant electronic systems for quality system support (e.g. for controlled documents, training management, change control)
- Scope may include medical device products
- Other responsibilities at management’s discretion
Education and Experience
- Bachelor’s degree; advanced/graduate degree preferred
- 8+ years experience in Quality or Quality-related roles
Essential Skills and Abilities
- A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect
- Excellent interpersonal, reading, writing, communication and public presentation skills, along with exceptional organizational skills
- Ability to identify and manage contract/vendor resources to support Quality-related goals
- Successful track record of working in a matrixed organization and building strong relationships with other functions and contractors/vendors
- Strong problem and conflict resolution skills
- Exceptional business acumen, analytical skills
- Ability to develop and manage expenditures in accordance with budget
- Travel up to 30% of time
Learn more at http://www.urovant.com