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Instructional Designer (Quality Assurance)

Gilead Sciences
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Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.
As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Specific Responsibilities:
  • Assists in the dissemination of a comprehensive training program for GxP applications to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
  • Organizes and conducts training and educational programs for personnel through formal classroom courses, one-on-one sessions, workshops, conferences and/or web-based training.
  • Assists in the development and maintenance of training content, training curricula and metrics in compliance with policies, procedures, and applicable regulations.
  • Performs administration and maintenance of the Learning Management System (LMS) including creation and maintenance of training items, training offerings, training curricula and training assessments.
  • Liaises with corporate/site partners to provide training support and ensure their departmental training needs are being met.
  • Coordinates with subject matter experts to ensure that prepared training meets stated objectives and has appropriate content.
  • Works with SMEs in developing On-the-Job Training and in managing the Training Effectiveness program.
  • Designs e-learning courses based on site and industry needs.
  • Acquires and maintains knowledge on scientific principles in order to deliver / design high quality training and effectively support the site.
  • Coordinates planning, organization, and implementation of projects within specified objectives.
  • Provides guidance and technical knowledge to more junior staff.
  • Provides additional support and assistance on tasks and projects as directed by the manager.
  • Keeps abreast of the basic requirements for compliance.
  • Works directly with stakeholders to continuously improve training requirements and curriculum.
  • Provides continuous internal customer support.
  • Meets assigned deadlines.
Essential Functions:
  • Designs and conducts site training program to meet compliance goals, meet development needs, and support operational excellence initiatives.
  • Designs, develops, and delivers high quality and high impact learning products, programs, and services that provide functional, GMP and product knowledge for site staff to achieve a high level of performance in their jobs.
  • Works on projects that are cross-functional in nature and that support the Product Operations, Quality and Compliance organizations.
  • Serves as subject matter expert on best practices and state of the art training delivery methodologies, curriculum development, etc.
  • Uses needs assessment tools to determine effectiveness of proposed training programs.
  • Interacts with all site departments to develop specifications for content of courses.
  • Prepares training session plans including the method, media, and documentation to be presented.
  • Leads group training sessions. Conducts follow up to determine applicability of course material.
  • Ensures translation of learning strategy into training deliverables in partnership with project managers, functional leaders, and internal stakeholders.
  • Collaborates with Management team to ensure optimal tracking of training and development records.
  • Evaluates the effectiveness of trainings, implementing modifications, when necessary, and monitoring training compliance for staff.
Knowledge, Experience & Skills:
Essential:
  • Demonstrates understanding of training and instructional design for adult learners.
  • Demonstrates understanding of e-learning tools for instructional delivery.
  • Demonstrates presentation skills with the ability to conduct training sessions.
  • Demonstrates functional and process knowledge to support the integrated design and development of training programs.
  • Experience in setting up and managing e-learning modules.
  • Demonstrates strong verbal, written, and interpersonal communication skills.
  • Proven organizational skills, planning skills, and ability to work effectively within teams.
  • Collaborative with a customer service mindset.
  • Demonstrates proficiency in Microsoft Office applications.
Basic Qualifications:
  • 6+ years of relevant experience and a BS or BA degree OR 4+ years of relevant experience and a MS degree.
Desirable:
  • Demonstrates ability to administer electronic Learning Management Systems (LMS).
  • Demonstrates proficiency of eLearning authoring applications (e.g., Captivate, Brainshark, Articulate, Vyond, etc.).
  • Demonstrates ability to lead cross-functional project teams.
  • Demonstrates knowledge and understanding of pharmaceutical manufacturing and quality assurance, aseptic and packaging processes and product transfer.
  • Prior experience working in a GMP environment.
  • Prior experience in pharmaceutical industry is preferred.