Note: Recruitment can be in South San Francisco, Basel and Welwyn
The Quality Associate ll independently performs a majority of the process management and training deliverables through leading and driving projects for PDQP and interdepartmental goals. Regularly applies quality compliance theories and principles to independently address a variety of issues of moderate scope. Primary impact through lead and facilitation.
Work independently, with support through management and mentoring.
Independently collaborate and facilitate with functional groups under supervision providing guidance on controlled documents (content, quality, document lifecycle), identifying gaps, addressing documentation needs, conducting process mapping sessions, developing training curriculums and suggesting process improvements.
Independently develops and reviews GCP and Controlled document training and associated materials. Develops instructional design materials for basic/simple trainings (include e-learning and instructor led training).
Desired: Able to utilize multimedia software platforms, authoring tools, and creates quality web-based trainings. Works with vendors to develop and deploy web based trainings. Perform user and quality assurance testing for all online courses, applications, systems and learning objects. Deliver complex training. Assists functions with development and implementation of training curriculas through the learning management system. Coordinate global cross functional/cross organizational trainings deployment, including training material development, audience identification, and deployment communication. Understanding of and applies GCP compliance and quality knowledge to trainings. Delivers GCP trainings and ability to answer questions with applied GCP knowledge.
Desired: applied knowledge in regulations (e.g. FDA, EU)
Develops and administrates internal processes and system (defining system/process requirements, working with vendor to build process/database, testing, maintenance).
Mentors and trains junior staff on GCPs and training development
Independently develops and reviews GCP and Controlled document training and associated materials.
Develops instructional design materials for basic/simple trainings (include e-learning and instructor led training).
Works closely with Subject Matter Experts (SME's) to identify key information and use e-learning to for distribution to a Global training audience. Education/Qualifications:
Bachelor’s degree or equivalent in a scientific field
Minimum:
5-7 years of experience in pharmaceutical or biotechnology industry, with at least 3 years in quality or process management.
Fluency in English language (written and spoken)
5-7 years Applied GCP knowledge
Experience with developing and implementing curricula/training for onboarding/induction of new hires and managers.
Experience, Skills, Knowledge:
Detailed oriented
Excellent oral and written communication skills
Solid training and presentation/facilitation skills.
Robust understanding of global drug development
Ability to work simultaneously on several projects
Demonstrated analytical, critical thinking and decision-making skills.
Project management skills and ability to work effectively and independently
Ability to work under aggressive timelines, demonstrated project management and time management skills
Solid applied knowledge of procedures, documentation practices, GCPs and regulations
D emonstrated ability to design and develop instructionally sound training programs
