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 Senior QA Manager, Pharmacovigilance Compliance. The position reports to the Head, GxP Quality Assurance.  The location of the position is in Brisbane, CA.

Summary Description

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

REQUIREMENTS

Education

  • S. or advanced degree in chemistry, biology, or related science

Experience

  • 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.

If you require any accommodations, please email careers@myovant.com.

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 www.dol.gov/ofccp.

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 www.dol.gov/ofccp.

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.