Job Description

Job Title: Specialist, Learning Systems & Compliance

Location: Seattle, WA (Hybrid - 50% onsite policy over two weeks, Tuesdays and Thursdays onsite, the other onsite day is flexible)

Duration: 6 Months

Work Schedule: Normal Business Hours

Job Description:

Top Skills:

• Minimum 2-3 years of experience in quality and compliance systems.
• Experience with EDMS and LMS required.
• Experience with Deviations and/or RCAs preferred.
• Prefer a minimum of 1 year of experience in learning and development.
• Technical writing skills preferred.

Position Summary:

The Specialist, Learning Systems & Compliance plays a crucial role in ensuring compliance within Global Patient Operations. This position focuses on collaborating with our Learning Management System (LMS) partners to ensure effective deployment of training, supporting Change Management for Global Patient Operations as the single point of contact, supporting Deviations/CAPA investigations, and creating content based on proposed CAPAs.

We are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology, and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contributes to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and our continued investment in our Cell Therapy capabilities, the growth potential of this science, and the ability to help patients, are incredible.

Duties/Responsibilities:

• Data Reporting: Generate and maintain regular compliance reports to share out to Global Patient Operations leadership for streamlined communication.
• System Integration: Work with IT and LMS administrators to integrate learning systems with other organizational tools and platforms. Actively engage in the identification, sharing, and adaptation of best training practices cross-functionally.
• Subject Matter Expert (SME): Create and maintain, as delegated, the Learning and Development governance documents (SOP/WI) in the DMS.
• Compliance: Ensure that training programs comply with relevant industry regulations and internal policies.
• Deviations/CAPAs: Support SCLT deviations and investigations to capture unexpected events and propose strategies to mitigate recurrence of events.
• Content Creation: Creating content based on proposed CAPAs as needed to fill training gaps as identified from root cause analysis (RCA) investigations.
• Change Management: Supporting contact for Global Patient Operations Impact Assessments. Attend CCRB Meetings to delegate Impact Assessments based on new proposed changes to capture needed improvements to processes and documents.

Critical Competencies:

• Results-oriented: A result-oriented individual, with a participative, strong personal work ethic, with a bias toward action. Establishes clear expectations, objectives, and priorities. Sets aggressive but achievable goals and consistently delivers. Diligently monitors progress and proactively addresses variances.
• Flexible & Entrepreneurial skills: The ideal candidate must be able to navigate complex environments and ambiguous situations. They will be a change agent in a rapidly transforming organization.
• Collaboration skills: Works effectively in a team-based organization, collaborates cross-functionally, and builds alignment around goals and objectives. Readily builds consensus and achieves agreement on key initiatives and priorities.
• Communication skills: Excellent communication and interpersonal skills. Effectively leads meetings. Strong presentation skills in both small and large group settings with internal and external stakeholders. Excellent listener; seeks broad input and feedback; frequent and effective follow-up.
• Quality mindset: Able to adhere to standard policies and procedures and work within a controlled document management system (DMS).
• Instructional Design: Works with content SMEs to create training based on needs analysis.

Position reports to: Manager, Global Patient Operations - Learning Systems & Compliance

Qualifications:

• Bachelor's degree in Education, Life Science, Technical Communication, or a related field.
• Minimum 2-3 years of experience in quality and compliance systems. (7+ years of experience or PhD would be overqualified.)
• Excellent verbal and written communication skills.
• Technical writing skills.
• Excellent project management and organizational skills.
• Prefer a minimum of 1 year of experience in learning and development.
• This position requires up to 10% travel.

Note: Candidates with strictly lab and/or manufacturing experience would not be a fit for this role. QA/QC, training, and compliance type roles would be better suited

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