Manager / Senior Manager, GxP Document Control and Training

Location
Brisbane, CA, United States
Posted
Jul 07, 2021
Ref
5376039002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

Summary Description

We are currently seeking a qualified, highly motivated, experienced individual for the position of Manager ? Senior Manager GxP Document Control and Training located at our Brisbane office. This individual will be responsible for the execution and maintenance of the GxP document control system and GxP training program by ensuring compliance to quality objectives and regulatory requirements are met. In addition, he/she will maintain Myovant's GxP Electronic Document Management System (eDMS) and Learning Management System (eLMS).

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. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Essential Duties & Responsibilities
  • Manage and maintain GxP controlled documents and training in Veeva.
  • Partner with standard operating procedures (SOPs) authors/owners in functional areas and assists in creating and/or revising documents (policies, SOPs, specifications, etc.).
  • Review controlled documents (SOPs, Work Instructions, etc.) content and exercise judgements to provide suggestions to author to ensure alignment with Myovant's controlled document procedures and best practices.
  • Review Document Change Controls, routes documents for review and approval and issue effective documents.
  • Collaborate with cross functional areas to establish training applicability for new or revised documents.
  • Develop and monitor the training curriculum/curricula on an ongoing basis to meet the relevant needs of the organization.
  • Provide quality perspective and expertise as the single Point of Contact for document management. Escalate issues as appropriate.
  • Provide user assistance and training on document control systems and procedures.
  • Perform day-to-day Document Control duties independently including: Process Document Change Request packages and review for correctness and completeness; monitor and update in-process documents.
  • Assist in the preparation of document control metrics and reports.
  • Participate in computer system change management and system validation.
  • Support Quality and Compliance initiatives as required.
  • Represent the quality team in meetings with various departments/stakeholders in order to establish priorities and deadlines for Quality and Compliance initiatives, as required.
  • Manages archival, storage, and retrieval of GxP records and archive room.
  • Participates in developing Standard Operating Procedures and training materials to ensure quality objectives are met.
  • Lead and coordinate other duties as assigned.

Core Competencies, Knowledge and Skill Requirements
  • Excellent communication and collaboration skills with demonstrated capabilities to manage and influence stakeholders in a matrix environment effectively.
  • Excellent writing skills and editing, formatting and organization skills.
  • Demonstrate GxP knowledge with a global understanding of phase appropriate application to regulations.
  • Excellent problem-solving abilities to independently resolve routine and complex issues.
  • Excellent customer-service orientation, high degree of professionalism, ability to work with limited direction and work successfully within a cross-functional team/partnership environment.
  • Demonstrate a positive, 'can do' and solution-oriented attitude.
  • Ability to multi-task and shift priorities quickly while working under tight deadlines.
  • Ability to learn and utilize computerized systems for daily performance of tasks.
  • Excellent organizational skills, attention to detail and solution focused.
  • Excellent project management skills to prioritize multiple tasks and goals and ensure timely and on-target accomplishment.
  • Ability to build trust and respect within the organization.

REQUIREMENTS

Education
  • Bachelor's degree Degree in a scientific field preferred.

Experience
  • Minimum of 5+ years of Quality Assurance experience within biopharmaceutical industry in a GXP environment and minimum of 2 years of experience with GxP Document Management and Training programs.
  • Working knowledge of Quality System standards (ICH Q10) and Quality Systems regulatory requirements.
  • Working knowledge of Veeva Quality Docs and Training systems is a plus.
  • Strong knowledge of system technology and administration
  • Previous experience with regulatory inspections is a plus.

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
  • Regularly required to operate standard office equipment.
  • Ability to work on a computer for extended periods of time.
  • Regularly required to sit for long periods of time, and occasionally stand and walk.
  • Regularly required to use hands to operate computer and other office equipment.
  • Occasionally required to stoop, kneel, climb and lift to 20 pounds

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