Senior Manager, Quality Assurance Program

Job Description

Job Description

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.

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.