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 enthusiastic individuals who share our excitement for this mission.
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Quality Assurance Manager located at our Brisbane, California office.
The individual will be responsible for serving as Business Process Owner (BPO) for the organization’s GxP electronic Document Management System (eDMS) and Learning Management System (eLMS). This includes managing day-to-day operations, change management for the operational systems, process improvements, supporting documentation, and user training for each system to ensure compliance with appropriate regulations and guidelines. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.
Essential Duties and Responsibilities
- Review and approve inputs into the eDMS and eLMS, such as changes to account permissions, system enhancements, and change controls.
- Act as main point-of-contact with the vendor to ensure the system continues to meet evolving business needs, articulating and tracking new product feature requests and enhancements.
- Create/revise procedures as needed to support operation and maintenance of the eDMS and eLMS.
- Ensures training assignments are fit-for-purpose and current as the system matures and processes evolve.
- Identify and implement process improvement initiatives related to the eDMS and eLMS.
- Administer user training as needed and when new system features are released.
- Oversee document and curricula periodic review processes.
- Monitor metrics associated with the systems to ensure compliance with relevant procedures.
- Provide Document Control and Training support for cross-functional team projects, particularly as it relates to new or modified uses of the eDMS or eLMS.
- Compile Document Control and Training metrics contributing to quarterly Quality Management Review meetings.
- Support inspection readiness activities relating to Document Control and Training activities and provide on-site and real-time support during regulatory agency inspections.
- Participate in developing and improving Standard Operating Procedures (SOPs) and Work Instructions pertaining to Document Control and Training processes.
- Assist with other Quality Systems and Compliance assignments.
- Demonstrate communication and collaboration skills with an ability to effectively manage and influence stakeholders in a matrix environment.
- Exercise good judgment and make decisions that are 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.
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, integrity, and trust building behavior.
- Must have excellent customer-service orientation, high degree of professionalism, ability to work with limited direction and work successfully within a cross-functional team/partnership environment.
- Ability to multi-task and shift priorities quickly while working under tight deadlines.
- Strong experience with GxP eDMS and eLMS systems, ideally serving as BPO.
- Ability to effectively identify business needs and gather system requirements to achieve alignment across various business functions and across a global organization.
- Strong PC experience and proficiency in MS Office (Outlook, Word, Excel, PowerPoint, SharePoint) a plus.
- Good organizational skills with a strong attention to detail and accuracy.
- Excellent written and verbal communication skills to build trust and respect within the organization.
REQUIREMENTS (Education and Experience)
- Bachelor’s degree in scientific discipline or related field preferred.
- At least 5-7 years of pharmaceutical experience in a GMP environment administering Quality Management Systems.
- Strong working knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs), as well as Quality System regulations and guidance documents.
- Experience with Veeva eDMS and LMS strongly preferred.
The well-being and safety of our employees is our top priority. Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based). Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
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