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We are currently seeking a dynamic, highly motivated, experienced individual for the position of Sr. QA Manager, PV Quality Assurance & Compliance. The position reports to the Head, GxP Quality Assurance. The location of the position is in Brisbane, CA.
The Senior Manager is responsible for QA oversight of GVP compliance to ensure patients safety, rights and welfare is protected. This individual will manage, assess and directly work to continuously improve and ensure appropriate GVP processes, systems and procedures are in place and in compliance with all corporate policies, global regulations and guidelines. She/he will ensure outsourced third parties such as contract research organizations (CROs), clinical sites, and other GCP/PV contract service providers are compliant and prepared for potential regulatory inspections and audits. Additionally, the position is responsible for PV training compliance. Will manage cross functional relationships with internal and external stakeholders including partners and function as the QA representative to drug safety, clinical development, clinical operations and commercial teams.
Essential Duties and Responsibilities
Partner with the Quality Assurance and Compliance function for the development, implementation and continuous improvement of Myovant Quality System required to assure PV compliance to corporate policies, procedures and global regulations.
Provide expert compliance advice on PV strategies, regulations, guidelines, processes, initiatives, and activities to help manage and mitigate risk.
Serve as the QA PV representative and collaborates with subject matter experts to revise current SOPs and initiate/develop new standards & procedures.
Contribute to the PV audit program by planning and, executing PV audits and working with auditees to resolve any non-compliance identified.
Review audit reports and liaises with appropriate internal and external stakeholders to develop or recommend corrective actions to findings. Communicate with stakeholders to prepare, prioritize and monitor mitigation measures; conduct follow up on documented actions to ensure that they are completed and documented within defined timelines.
Support inspection readiness activities including but not limited to monitoring for noncompliance and ensuring responsible functions mitigate risks. Collaborate with Quality & Compliance function to conduct inspection readiness training and one-one SME practice sessions as required.
Actively participate in and supports PV inspections, partner audits, mock inspections, onsite or remotely to ensure successful outcome.
Work with Quality Assurance and Compliance function to drive the development and approval of pharmacovigilance training materials and programs both internal and external including contract service providers and alliance partners.
Responsible for ensuring the accuracy, completeness, and audit readiness of PVG training records and documentation.
Develop and participate in the preparation of PV specific periodic metric reports related to Quality Incident Investigations, CAPAs, audit, training; reviews, monitor and trend root cause analyses for non-compliance metrics.
Review Pharmacovigilance Agreements with business partners.
Collaborate with Drug Safety and Pharmacovigilance group to ensure maintenance of Pharmacovigilance System Master File (PSMF) and supporting annexes.
Promote continuous education with regards to PV regulations and industry good practices.
Keep abreast of the emerging regulatory intelligence requirements for PV compliance. Assesses impact of changes on current practices and processes and coordinate with other functions to develop recommended plans for implementation.
Other projects when assigned
Core Competencies, Knowledge, and Skill Requirements
Expert knowledge of regulatory requirements pertaining to GVP, which may include working knowledge of safety reporting in clinical trials, post marketing surveillance, case processing and reporting to Regulatory Authorities globally; knowledge of GCP a plus.
Ability to read, analyze, and interpret standards, procedures, or governmental regulations/guidance.
Experience applying risk management principles to decision makings
Experience in supporting Regulatory Authority GCP and BIMO inspections
Experience in the development and maintenance of compliance monitoring and pharmacovigilance SOPs and processes
Extensive experience in quality systems, establishing and tracking metrics, compliance monitoring, and the development and maintenance of SOPs and training programs
Experience with implementation of Veeva
Experience with GMP or GCP operations
Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
Exercise good judgment and make quality decision based on risk management and 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
BS. or advanced degree in chemistry, biology, or related science
Minimum of 8+ years of direct QA experience with a regulatory authority in GxP and quality assurance pharmacovigilance compliance environment within the pharmaceutical/ biopharmaceutical industry
Knowledge and thorough understanding of global Pharmacovigilance regulatory requirements and industry best practices and an understanding of the principles of quality management.
Broad knowledge of risk-based quality systems approaches and continuous process improvement principles.
Experience with audits and regulatory inspection support
Ability to travel both domestic and internationally as needed
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
Internal Number: 654
About Myovant Sciences, Inc
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 develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.