Sr Director, GCP Quality Assurance

Position Summary

Rigel Pharmaceuticals is seeking an experienced Senior Director, Good Clinical Practices (GCP) to serve as the enterprise leader responsible for designing, building, and leading Rigel’s global GCP quality framework across an active clinical development portfolio. This role operates at the intersection of strategy, execution, and transformation, driving the design, implementation, and continuous evolution of a modern, risk-based, and inspection-ready GCP quality ecosystem. The Senior Director will lead cross-functional alignment, influence senior stakeholders, and embed a proactive quality culture that enables speed, compliance, and innovation. This role serves as the internal subject matter expert and program lead across guidance, execution, inspection readiness, and continuous improvement. The Senior Director operates strategically while remaining hands-on, ensuring scalable, risk-based systems that support growing, development and commercial goals.

As a key member of the Quality leadership team, this individual will scale systems, lead organizational change, and ensure sustainable compliance aligned with corporate growth, pipeline expansion, and potential commercialization.

Salary Range: $260,000 to $265,000

Essential Duties And Responsibilities

Enterprise Program Leadership & Strategy

• Define and lead Rigel’s global GCP quality plan aligned with corporate and clinical objectives
• Establish and maintain an integrated GCP compliance program with appropriate Pharmacovigilance (PV) interfaces, aligned with FDA, EMA, ICH, and global regulatory requirements
• Build and continuously improve a scalable, risk-based quality management system appropriate for a public biopharmaceutical company with an active development pipeline
• Integrate GCP with Pharmacovigilance (PV), Regulatory, and broader GxP domains to ensure end-to-end compliance
• Serve as trusted advisor to Clinical Operations, Biometrics, Clinical Science, Supply Chain, Drug Safety, Regulatory, and Technical Operations
• Support digital and scalable solutions to modernize quality operations and reporting
  
  

Operational Oversight

• Lead SOP development, harmonization, and governance framework design
• Own and execute the annual GCP/ PV audit plan (sites, CROs, vendors, internal processes)
• Oversee audits, CAPAs, root cause analysis, effectiveness checks, and trend reporting
• Ensure robust CRO/vendor oversight
• Provide end-to-end quality oversight for clinical trial development and conduct
  
  

Inspection Readiness & Regulatory Leadership

• Lead GCP inspection readiness strategy and execution
• Prepare teams for FDA, EMA, and global inspections and serve as GCP lead during regulatory interactions
• Conduct mock inspections and readiness assessments
  
  

Training, Culture & Governance

• Develop role-based GCP training programs and ongoing regulatory education
• Drive change management initiatives to strengthen quality culture
• Establish quality KPIs and metrics; present ongoing risk and compliance insights
• Monitor evolving regulatory expectations and industry best practices
  
  

Knowledge And Skill Requirements

• 12-15 years of progressive GCP and/or clinical operations experience in biopharma; development and commercial-stage experience preferred
• Demonstrated experience building and scaling GCP quality systems and leading audit programs
• Direct experience supporting global regulatory inspections
• Strong expertise in ICH GCP (E6 R2/R3), FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), EMA guidance, and risk-based quality management
• Hands-on, solution-oriented mindset with the ability to balance big-picture strategy and detailed execution
• Bachelor’s degree in life sciences or related field required. Advanced degree (MS, PhD, PharmD, or equivalent) preferred.
  
  

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. Ability to travel as 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.