Sr Mgr QA

Summary:

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 L0 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 L0 Management Reviews.
• Lead the digitalization of GxP L0 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
  
  

Top 3 Must Have Skill Sets:

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

Day to Day Responsibilities:

• Lead the execution of GxP Quality Management Review
• 2 Compile and ensures quality content of GxP QMR prior to distribution
• Lead continuous improvement efforts
• Collaborate with cross-functional topic owners on the creation of forum material.
• Leads the authoring and maintenance of GxP QMR documentation.
  
  

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on a number of factors, including but not limited to, a candidate’s qualifications, skills, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.