POSITION SUMMARY: The Quality Assurance Program Manager is responsible for providing operational support that enables the Quality Assurance organization to execute efficiently and consistently. This role coordinates business-critical QA activities across multiple concurrent priorities while managing Quality Systems, Document Control, and Learning Management System (LMS) processes that support Rigel's GxP operations.
The successful candidate is a highly organized, hands-on professional who thrives in a fast-paced environment, enjoys bringing structure to complex activities, and consistently delivers accurate, high-quality work. This individual is recognized for exceptional follow-through, attention to detail, proactive communication, and the ability to effectively prioritize competing demands while ensuring that critical quality deliverables remain on track.
Salary Range: $140,000 to $170,000
ESSENTIAL DUTIES AND RESPONSIBILITIES: - Coordinate Quality Assurance activities supporting cross-functional projects, Rigel commercial partners, and GMP vendors to ensure timely completion of business-critical deliverables.
- Develop, maintain, and continuously update the integrated Quality Assurance workplan, ensuring alignment of departmental priorities, milestones, resource needs, and critical deliverables across multiple concurrent initiatives.
- Track priorities, action items, and milestones across multiple concurrent activities, proactively identifying potential risks and following through to completion.
- Participate in cross-functional meetings, document key decisions and action items, and monitor progress to ensure timely execution.
- Provide regular updates to QA leadership and cross-functional stakeholders regarding project status, priorities, and deliverables.
- Serve as owner of the shared QA mailbox, ensuring timely triage and coordination of Quality-related requests.
- Compile and report Quality metrics and key performance indicators (KPIs) that support operational oversight and continuous improvement.
Quality Systems & Document Control
- Serve as system administrator for Dot Compliance EDMS/EQMS (or equivalent electronic Quality Management System), maintaining system configuration, user roles, permissions, document structures, and overall system integrity.
- Manage the complete lifecycle of controlled documents, including creation, routing, review, approval, revision, archival, and obsolescence in accordance with applicable GxP requirements.
- Ensure the integrity, accessibility, and compliance of controlled quality documentation.
- Develop, maintain, and continuously improve document templates, formatting standards, and document control processes.
- Provide technical support and guidance to new users, document authors, and reviewers regarding document preparation, formatting, workflows, and system functionality.
- Apply advanced Microsoft Word skills, including styles, templates, section management, tables, cross-references, and complex formatting, to produce high-quality controlled documents.
Learning Management System
- Administer the GxP Learning Management System within Dot Compliance.
- Develop and maintain curricula, training assignments, learning activities, and assessments.
- Monitor training compliance and completion, troubleshoot system issues, and partner with functional areas to ensure training requirements remain current.
- Generate reports and metrics supporting training effectiveness and regulatory compliance.
KNOWLEDGE AND SKILL REQUIREMENTS: - Bachelor's degree in a scientific, technical, or related discipline.
- Minimum six years of experience in Quality Assurance, Quality Systems, Document Control, Program Coordination, or related GxP functions within the pharmaceutical, biotechnology, or life sciences industry.
- Working knowledge of applicable cGMP, GLP, and/or GCP regulations.
- Experience administering or supporting electronic document management or quality management systems (e.g., Dot Compliance, Veeva, MasterControl, or equivalent).
- Experience administering Learning Management Systems is preferred.
- Advanced Microsoft Word skills, including styles, templates, section formatting, and complex document management.
- Demonstrated ability to successfully manage multiple competing priorities in a dynamic environment without requiring close supervision while maintaining exceptional attention to detail.
- Strong organizational, administrative, and project coordination skills.
- Excellent written and verbal communication skills with the ability to collaborate effectively across functions and with external partners.
- Positive, proactive, solution-oriented approach with a strong sense of ownership and accountability.
- Proven ability to build strong working relationships across departments through professionalism, responsiveness, and collaboration.
COMPENSATION AND BENEFITS: Rigel offers eligible employees a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; paid time off; paid company holidays; a 401(k) plan; and other benefits.
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. Some travel may be required.
