Stage 4 Solutions · 18 hours ago
Quality Compliance & Learning Specialist - Pharma (Hybrid – Seattle, WA)
Stage 4 Solutions is seeking a Quality Compliance & Learning Specialist - Pharma for a global pharmaceutical client. This role is crucial for ensuring compliance within Global Patient Operations by collaborating with Learning Management System partners, supporting Change Management, and managing Deviations/CAPA investigations.
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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
Qualification
Required
Minimum 2-3 years of experience in quality and compliance systems. (7 + yrs experience overqualified, PhD overqualified)
Experience with EDMS and LMS required
Excellent project management and organizational skills
Bachelor's degree in Education, Life Science, Technical Communication, or a related field
Preferred
Experience with Deviations and or RCAs
Technical writing skills
Prefer minimum 1 year experience in learning and development
Benefits
Health benefits
401K
Company
Stage 4 Solutions
Stage 4 Solutions is a management consulting firm that provides marketing solutions services.
Funding
Current Stage
Growth StageRecent News
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