Job Details

POSITION SUMMARY:

QA Program, Document Control, and Learning Management System (LMS) Manager is responsible for three key functions:

1. QA Program Management: coordinating quality activities to support critical internal and external deliverables. This position supports seamless execution of QA activities in cross-functional environment and enables QA team success by tracking, prioritizing, and mobilizing.
2. QA Document control: management, operation and upkeep of the Document Control System to support GxP (GMP, GLP, & GCP) programs
3. GxP learning management: managing LMS to ensure all GxP employees complete the required GxP relevant training, develop assessments/quizzes and activities/tools for effective learning and training

Salary Range:

Premium: CA/NY $150,000 - $165,000

National: $135,000 - $148,000

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Coordinate QA activities (both project-specific and on-going) ensuring deliverables/documents are completed. This includes, but is not limited to
  • Campaign-readiness (MBRs, specifications, etc.)
  • Batch release
  • EQMS records management (Complaints, QEs, CRs and CAPAs)
  • QA support for Rigel's partners
  • QA engagement and collaboration with Rigel's vendors
  • Inspection/audit readiness at Rigel
  • Product launches
  • QA support for M&A activities
  • QA support to enable clinical trial readiness
• Define, compile, and monitor KPIs to measure performance quality processes.
• Provide progress updates to cross-functional teams on key deliverables.

• Maintain a Document Control System for internal and external controlled documents, ensuring document data integrity, control and accessibility to Rigel users.
• Coordinate controlled document lifecycle and document change control activities including drafting, review/ adjudication, approvals, and obsolescence.
• Design and implement templates for SOPs and other controlled documents.
• Serve as an owner of SOPs describing EDMS processes
• Serve as owner and administrator of EDMS, build and maintain document structure, control document access, set and maintain user roles. Monitor and maintain files in EDMS.
• Manage GxP Learning Management System
• Track training completion and compliance, troubleshoot LMS system issues, develop training materials, establish curricula, collaborate with stakeholders to identify training needs, and generate reports on training effectiveness and compliance

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor's degree in technical/scientific field
• Previous Document Control and project management experience of at least 6 years
• Knowledge of relevant cGMP/GLP regulations
• Excellent organization and project management skills
• Demonstrated skills in using Learning Management Systems (LMS)
• Experience working with external vendors/partners
• Expert-level knowledge of MS Word
• Strong technical writing and editing skills
• Superior attention to detail
• Collaborative mindset, strong interpersonal and communication skills
• Ability to handle changing priorities in a fast-paced environment
• Must be pro-active, self-starter, and solution-focuses

WORKING CONDITIONS:

• PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• WORK ENVIRONMENT: The noise level in the work environment is usually moderate.

Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.