Senior GxP QA Manager

3 days ago

Thousand Oaks, United States Beacon Hill Full time

Sr GxP QA Manager needed in Thousand Oaks CA


This position will primarily lead the execution of GxP Quality Management Review, compile and ensures quality content of GxP QMR prior to distribution, and leads the authoring and maintenance of GxP QMR documentation. He/she lead continuous improvement efforts and collaborate with cross-functional topic owners on the creation of forum material.


Job description:


This position is a key member of the GxP Management Review Governance Team within the Quality Systems and Services organization. The QA Sr Manager for GxP Governance, will execute required activities to coordinate, prepare, execute and document the execution of GxP Quality Management Reviews.


Position Responsibilities will include, but are not limited to:

  • Providing hands-on support on the development, execution and coordination of activities related to the execution of the GxP Quality Management Review.
  • Coordinating and Facilitating material creation and preparation sessions.
  • Working with cross functional metric owners to ensure reporting of applicable metrics for GxP Management Reviews.
  • Lead the digitalization of GxP Quality Management Review metrics.
  • Promoting cross-functional collaboration to develop a metrics digitalization capabilities and information gathering to support MR key activities.
  • Providing the quality management team with information on the performance of metrics and progress of Management Review execution activities
  • Lead the create and maintain GxP Quality Management Reviews documentation.
  • Collaborate with Stakeholders: Work closely with and support the GxP Governance Team, and other key stakeholders in key GxP Quality Management Review Activities
  • Lead coordination activities in support of GxP Management Review preparation including: Coordinate material generation, scheduling of review sessions, support the creation of presentation and story boards.
  • Support the creation of Visual Content: Develop graphics, animations, and visualizations to communicate complex scientific and clinical concepts in an engaging and clear manner for Executive Level Leadership)
  • Utilize Software: Work proficiently with tools such as Adobe Creative Suite and visualization tools, as well as generative AI image software to produce high-quality content adequate for C-Suite Leadership Level.
  • Manage Content Plans: Develop and support workflows, for deliverables with overlapping timelines, that follow proper review and approval process to ensure content accuracy, effectiveness, and message buy-in from, including protection of confidential information


Basic Qualifications:

  • Doctorate degree and 2 years of experience OR Master’s degree and 6 years of experience OR Bachelor’s degree and 8 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
  • In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Top must have skills:

  • Advance Project Management Skills
  • C-Suite Content Creation Skills
  • Executive Level Communication Skills

Ideal skills:

  • Strong time management skills, multi task and manage multiple projects, executive level communicator.
  • Content creator: puts together story lines on deliverables able to create presentations.
  • C-Suite Content Creation Skills or Power point or other tools to translate visuals.
  • Quality background Quality management system in operations and R&D.
  • Analytical skill set, experience with dashboards and automation of dashboards.
  • Interpersonal relationship skills, ability to deal with different behaviors and different type of people, and savvy enough to navigate cultural differences.
  • Ability to interact cross functionally Operate operations, Reg affairs safety, commercial, and DTI.
  • Nice to have budget management and portfolio skills.

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