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Senior Manager GCP Quality Assurance

Employer
Myovant Sciences
Location
Brisbane, CA
Start date
Sep 19, 2022

View more

Discipline
Quality, Quality Assurance, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay
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Job Details

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.


Summary Description

We are currently seeking a qualified, highly motivated, experienced individual for the position of Sr Manager of GCP Quality.  This position may be located in the Brisbane office or remotely.  This individual will be responsible for managing the GCP audit program, as well as providing compliance oversight for GCPs, and GLPs activities.


Essential Duties & Responsibilities

  • Develop and administer a risk-based GCP audit program for domestic and global clinical trials.
  • Establish and implement procedures and tools for the conduct of investigational site, study, TMF, CSR and vendor audits.
  • Provide first line quality support to study teams as needed
  • Plan, organize and conduct audits of external vendors including , but not limited to CROs, laboratories, clinical sites, as well as studies,  and study documentation such as TMFs and CSRs.
  • Partner with Quality & Compliance to support the planning and conduct of internal GCP audits.
  • Review and/or prepare audit agendas, audit reports and audit responses within defined timelines.
  • Actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance.
  • Escalate and manage the remediation of critical findings in a timely manner.
  • Support business with management of Quality Incidents and relevant actions.
  • Manage external auditors and ensure they are trained & have the required experience and knowledge to perform assigned audits.
  • Plan, organize and lead for cause audits of investigational sites and vendors.
  • Compile, present and maintain key performance metrics for the GCP/GLP audit program in support of quarterly quality management reviews.
  • Lead inspection readiness and oversight activities for inspections conducted at investigator sites and vendors. Coordinate review and resolution of inspector findings/observations with the site or vendor. 
  • Support regulatory inspection readiness and remediation activities
  • Perform other duties as assigned.

 Core Competencies, Knowledge and Skill Requirements

  • 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
  • Strong organization and project management skills

REQUIREMENTS

Education 

  • Bachelor’s degree required; advanced degree in a scientific field preferred

Experience

  • At least 7 years of experience in clinical Quality Assurance, specifically managing audits.
  • Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice (GCP)
  • Strong knowledge of risk-based GCP audits for investigational sites and vendors
  • Experience with all phases of clinical trials
  • Strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, including database and eCRF validation procedures, eCTD Quality Assurance, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
  • Experience in supporting inspection-readiness activities resulting in successful FDA inspection
  • PV expertise is a plus

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.

Equal Employment Opportunity

 

#LI-BJ1

Company

We aspire to be the leading healthcare company focused on redefining care for women’s health and prostate cancer. Our experienced team brings significant breadth and depth of expertise in drug development, combined with a commitment to develop new treatments for women suffering from uterine fibroids, endometriosis, and infertility, and men suffering from prostate cancer. We strive to improve the lives of millions of people, while building an innovative, dynamic, and collaborative company where employees thrive.

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Find Us
Website
Phone
650-392-0222
Location
2000 Sierra Point Parkway, Suite 900
Brisbane, CA 94005
United States
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