POSITION SUMMARY:

The Director, Vendors and Partners Quality Management provides strategic and operational oversight of Rigel’s external quality network, including global commercial partners and GxP vendors. This role ensures quality and compliance alignment with partners who hold Marketing Authorizations for Rigel’s products outside the USA. This role also drives quality and compliance with Rigel vendors supplying GxP materials or services. The Director is responsible for managing quality agreements, engaging in partner and vendor audits, and the exchange of quality documentation to support regulatory filings and inspections.

Salary Range: $210,000 to $250,000

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Establish, maintain, and manage Quality Agreements with partners and vendors to ensure clear GxP responsibilities.

• Lead the vendor quality management program through select-implement-manage-decommission lifecycle across GMP, GCP, and GLP areas.

• Manage partner complaint investigations and ensure compliant communication and documentation closure.

• Oversee vendor and partner audits, including scheduling, conduct, reporting, and follow-up actions.

• Coordinate exchange of quality documents with partners to support regulatory submissions and inspections.

• Lead Rigel Change Management program for clinical and commercial products , applying phase-appropriate and risk-based framework and ensuring compliance with regulatory requirements.

• Serve as a Quality lead for Rigel Technology Transfer projects

• Provide Quality support for assessment and implementation of new assets.

• Develop and maintain metrics (KPIs) to monitor vendor and partner quality performance.

• Collaborate with Regulatory, Legal, and Supply Chain to ensure partners and vendors meet contractual and regulatory obligations.

• Provide QA input into business development and alliance management processes

• Stay current with global regulatory expectations impacting partner and vendor oversight programs.

• Represent Rigel Quality in governance meetings with external partners and key suppliers.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.

• 12+ years of pharmaceutical Quality Assurance experience, including vendor and partner management.

• Strong understanding of global GxP regulations and supplier quality requirements.

• Experience leading audits and managing external Quality Agreements.

• Knowledge of both commercial and clinical product quality systems and regulatory submissions.

• Exceptional interpersonal skills for effective collaboration with external partners and cross-functional stakeholders.

• Ability to travel domestically and internationally for audits and partner meetings.

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.