Senior Quality Management Systems (QMS) Associate (Contractor)
Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.
Position Summary
The primary role of the Senior QMS Associate will be to manage Amicus document management and/or training needs for the organization, including curriculum development, and job code maintenance. Coordinate and execute system training for key business partners for the electronic systems for learning management and/or document management. Provide administration support for the systems to ensure operation and maintain the validated state.
This role will work to effectively maintain employee curriculums and/or procedural changes through interaction with Business Partners (GxP, Compliance, Safety, Facilities, etc.) and ensure appropriate reporting, notifications and metrics are employed. In addition, maintain and provide system reports, training metrics and/or document metrics for audits and health authority inspections. Support any activities for record retention, archive and system maintenance related to the electronic management systems employed.
Roles and Responsibilities
1. Support the implementation of electronic system processes as it relates to user requirements, UAT, implementation and training for document management and/or training. Support ongoing activities related to changes/enhancements and upgrades for the electronic document management and/or training system identified for use.
2. Continuously support and develop GxP curriculums and job codes to work with business areas to optimize training and support on time completion of training via curriculum management or as business needs arise.
3. Develop and/or optimize training or document management procedures ensuring the effectiveness of the process and we are executing the systems against the documented procedures.
4. Identifying “off the shelf” e-learning programs, as needed to support GxP training across the organization.
5. Develop and report metrics on document management and/or training and communicate at a minimum to GxP business partners to ensure that document management and training goals or projects are reached
6. Oversee and provide solutions for the document management system and/or training system in use. Manage or lead projects to translate global processes and/or system requirements to the business to ensure standardization and GxP activities are maintained.
7. Provide training and maintain training documentation to support document management users (read only, creator/revisor, approvers etc.) and or training users on document management and/or training systems.
8. Implement training audiences, curriculum, and job codes to support Compliance training program as directed by SME.
9. Retrieve reports to support audits and health authority inspections and participate in inspections
10. Support Quality Management System as needed or project activities.
Requirements
Educational Requirements
BA or BS in related technical field is required
Professional Work Experience
1. Five to ten years’ experience working in a regulated industry (Pharmaceutical, Biotechnology, or Devices)
2. Familiarity and working principles with Document Management Systems, Change Control or Learning Management systems functionality is required.
3. Working knowledge of FDA, ICH, and Global regulations and best practices for Document Management and/or Training/Learning Management.
4. Experience in database management, reporting, and trending systems.
5. Previous experience in systems such as Master Control, TrackWise, Documentum, Compliance Wire, and/or Learning Management experience required.
Other skills/Attributes
• Demonstrated alignment with Amicus Mission Focus Behaviors
• Passion for rare disease and patient focused
Travel
• Ability to travel up to 0 – 5%.
We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.
Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.
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