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.
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.
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Equal Employment Opportunity