Quality Compliance & Learning Specialist - Pharma (Hybrid – Seattle, WA)

We are seeking a Quality Compliance & Learning Specialist - Pharma for a global pharmaceutical client. You will play a crucial role in ensuring compliance withing Global Patient Operations. This position focuses collaborating with our Learning Management System (LMS) partners to ensure effective deployment of training, support Change Management for Global Patient Operations as the single point of contact, supporting Deviations/CAPA investigations, and creating content based on proposed CAPAs.

This is a 40-hour per-week, 6-month contract (extensions possible), 50% onsite role at the client’s office in Seattle, WA. Tuesdays and Thursdays onsite, the other onsite day is flexible. This position requires up to 10% of travel.

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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.
  
  

Requirements

• Minimum 2-3 years of experience in quality and compliance systems. (7 yrs experience overqualified, PhD overqualified)
• Experience with EDMS and LMS required
• Experience with Deviations and or RCAs preferred
• Technical writing skills preferred
• Excellent project management and organizational skills.
• Prefer minimum 1 year experience in learning and development
• Bachelor's degree in Education, Life Science, Technical Communication, or a related field
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Quality Compliance & Learning Specialist - Pharma (Hybrid – Seattle, WA) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $50/hr - $57.01/hr