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 Director of Quality Systems. The position reports to the Executive Director, Quality Systems & Compliance. The location of the position is in Brisbane, CA.
As a leader in Myovant’s QA function, the Director of Quality Systems will serve as strategic and tactical professional to lead the Quality Systems group and will be responsible for enhancement and management of quality systems ensuring compliance with global regulations and standards set forth by governing regulatory and accrediting agencies. This new role will be highly visible in a dynamic environment and will directly be responsible for ensuring that the Myovant's Quality Systems enable and facilitate compliance in a phase-appropriate manner (pre-clinical through commercial).
The individual will work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through to achieve target quality objectives. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties and Responsibilities
- Accountable and responsible for the GxP Quality Management System (QMS); ensures phase appropriate QMS built on a framework of procedures/policies, compliance to all applicable regulations, is scalable and appropriate for the organization and product portfolio. In, addition, oversees the design, development, roll-out and maintenance of electronic Quality Management Systems, and adherence to regulatory requirements, policies and procedures.
- Responsible for management of Quality Agreement (QAG) life-cycle process with GMP Contract Service Providers and Partners. Ensures timely establishment and administration of QGAs through close collaboration with internal stakeholders to assure agreements are in place and kept up to date.
- Manage and facilitate Quality Management Review process. Maintain, monitor, and analyze compliance KPI/metrics to track and trend the state of the QMS and drive quality system effectiveness.
- Administer the yearly Quality Planning process. Track and communicate progress of Quality Plan related activities including status, timelines and risk mitigation strategies to ensure completion.
- Assists in hosting, managing, and facilitating regulatory inspections and partner audits.
- Key contributor to the GxP internal audit program, GMP supplier management and external audit lifecycles.
- Play an active role in annual mock recall or any recall activities of Myovant products.
- Author and review sections of the Annual Product Quality Review (APQR) related to Quality Systems. Assist in obtaining required data from GMP Contract Service Providers and/or Partners for Myovant’s (APQR) and provide APQR Report to Partners, as required.
- Responsible for the overall readiness of the QMS to ensure programs are compliant and ready for regulatory inspections.
- Support budget creation and resource allocation decision-making within the organization.
- Manage direct reports all the while driving a culture of excellence by motivating employees to perform at their highest ability.
REQUIREMENTS (Education and Experience)
- Demonstrate good knowledge of QA systems principles, concepts, industry practices, and standards.
- Keen understanding of US and international (e.g., EU, ICH) GxP regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
- Extensive knowledge and competence in core Quality processes, including deviation, CAPA, change control, training, quality agreement, and supplier management.
- Experience interfacing with regulatory authorities to present company methodologies and deliverables during inspections.
- Sound critical thinking and ability to assess interdependencies when making compliant risk-based decisions.
- Ability to manage all aspects of Quality Systems, paper and electronic systems as well as making any value-added enhancements.
- Ability to author and critically review Policies and Procedures.
- Excellent interpersonal and communication skills and ability to develop strong collaborative internal and external relationships; must be able to positively influence stakeholders in order to achieve results.
- 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.
- Thought leader with track record to formulate and integrate functional strategies with corporate objectives and translate them into actionable deliverables.
- High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.
- Ability to build and manage a high performing group; attract, retain, and coach best talent.
- Develops direct reports in their career paths, particularly ensuring that a successor is evolved.
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline.
- Minimum 10-15 years of relevant work experience with biotechnology or pharmaceuticals industry in a GXP environment and at least 6-8 years in Quality Systems.
- Strong working knowledge of 21 CFR Parts 210, 211, EudraLex Volume 4 and related Annexes, and ICH guidance documents
- Broad knowledge of risk-based quality systems approaches systems and continuous process improvement principles.
- Proactive in identifying opportunities for continuous improvement along with strong problem-solving skills.
- Attention to detail as well as a crisp, clear and concise style in written and oral communications.
- Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment.
- Experience with audits and regulatory inspections.
- Ability to travel both domestic and internationally, as needed.
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.
If you require any accommodations, please email email@example.com.
Equal Employment Opportunity