Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.

We are currently seeking a dynamic, highly motivated, experienced individual for the position of Director, IT Compliance. The position reports to the Executive Director, IT.  The location of the position is in Brisbane, CA.

Summary Description

In this hands-on role, the individual will provide management and oversight of IT Quality & Compliance policies, strategies, and activities.   This position will also have system ownership responsibilities for Myovant’s corporate Learning Management System (non-GxP LMS).  Other job duties may include but are not limited to resource planning, project planning, execution, and operations.  In addition, this position will partner with cross-function stakeholders (including but not limited to Legal, Quality, Accounting, and Computer System Validation) to develop IT policies and procedures that align with corporate needs.

Essential Duties and Responsibilities

  • Facilitate the creation and modification of all technology-compliance policies, procedures, and systems to ensure regulatory, compliance, and quality needs are met.
  • Oversee and manage the compliance aspects for GxP, SOX, GDPR of various IT applications for HR, Finance, Tech Ops, R&D and GxP applications including coordination with internal/external auditors on quarterly and annual reviews.
  • Partner with Quality, Legal, and Accounting to identify associated IT-compliance control gaps (GxP, SOX) and oversee the documentation, implementation and testing of the entire IT-compliance-control portfolio.
  • Develop and direct IT-compliance-control monitoring programs to meet compliance and organizational efficiency and to ensure IT-compliance-related risks are managed to the appropriate level of acceptable residual risk.
  • Implement and maintain an IT-compliance issue-management tracking-and-resolution process that will address known issues, according to severity and potential impact to the organization.
  • Assess and report the levels of IT-compliance risk to key stakeholders and present recommended pathways to minimize risk long term.
  • Manage the overall IT-compliance-related budget/financial spend in accordance with the desired IT-compliance risk tolerance of the organization.
  • Partner with IT Quality to develop and align on optimal process for computer system validation of GxP systems
  • Manage the Myovant System Development Lifecycle (SDLC) for Myovant infrastructure and computerized systems.
  • Collaborate with Computerized System Validation group on ensuring compliance in computerized system validation lifecycle and GxP System Periodic Review programs.
  • Manage the lifecycle of documents such as procedures, instructions, and change control within IT to ensure timely review, approval, execution, and storage.
  • Manage internal and external resources on project basis and push progress to ensure deliverables are on-time and on-quality
  • Act as system owner for corporate non-GxP LMS
  • Develop and manage training matrix
  • Oversee all maintenance and support activities
  • Partner with functions to ensure training compliance goals are met
  • Other projects when assigned

Core Competencies, Knowledge, and Skill Requirements

  • Extensive knowledge in computer system validation (CSV) or IT Quality/Compliance experience in the pharmaceutical industry. Experience in computer system validation (CSV) is a plus.
  • Successfully manage and facilitate IT Quality audits and inspections.
  • In-depth knowledge of pharmaceutical regulations including 21 CFR Part 11, GAMP 5, SOX, GDPR and other best practices for compliance.
  • Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
  • Exercise good judgment and make decision that is appropriate for the organization
  • Results-driven, take initiative and ownership to accomplish work
  • Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
  • Strive for continuous improvement and embrace innovative ideas in daily work
  • Extensive experience developing and creating CSV deliverables: risk assessment, validation plan, procedures, testing and documentation.
  • Broad experience with IT solutions for quality management, regulatory submissions, controlled document management solutions and clinical development
  • Advanced knowledge of Microsoft Word and Excel.
  • Past experience in technical writing within the biotech/pharmaceutical industry is a plus
  • Familiarity with electronic document management systems a plus.



  • Bachelor s degree in Computer Science, MIS, or a related computer-oriented discipline.
  • Certifications including PMP, ITIL, and CISA a plus.


  • 12+ years of experience in managing Information Technology within biotech/pharmaceutical industry with 5+ years leading an IT team and supporting validated GxP environments.
  • Experience with overseeing an environment with validated systems, collaborating with regulatory and quality groups to establish a validation program and oversee validation processes.
  • Experience with validation and management of cloud-based applications including those for quality management and learning management systems.
  • <10% travel may be required

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

If you require any accommodations, please email

Equal Employment Opportunity

Apply for this Job

* Required

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at Myovant Sciences are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.