POSITION SUMMARY: The Senior Manager, Quality Assurance, Quality Operations is responsible for executing day-to-day GMP Quality Assurance activities supporting commercial and clinical products manufactured and tested by Rigel's global network of contract manufacturers and laboratories. The role provides operational Quality oversight throughout the product lifecycle, including manufacturing readiness, manufacturing and testing support, batch disposition, change management, and Quality oversight of Quality Control activities.
National $158,000 to $190,000
Premium Market (SFBA/NYC/Boston Area) $175,000 to $210,000
ESSENTIAL DUTIES AND RESPONSIBILITIES: Manufacturing Readiness
- Review and approve GMP manufacturing, analytical, validation, and quality documentation supporting commercial and clinical manufacturing campaign readiness.
- Partner with Technical Operations, Supply Chain, Regulatory Affairs, and external manufacturers to support manufacturing readiness and uninterrupted product supply.
- Review and approve specifications, analytical methods, sampling plans, protocols, and other Quality Control documentation supporting commercial and clinical manufacturing.
Manufacturing, Testing & Quality Oversight
- Provide Quality oversight of manufacturing and testing activities performed by contract manufacturers and laboratories.
- Lead or support investigations of deviations and OOS/OOT events, ensuring timely completion, robust impact and root cause analysis, and appropriate CAPAs.
- Provide Quality oversight of Quality Control activities, including analytical investigations and laboratory documentation, as applicable.
- Provide Quality oversight of Rigel's stability program in partnership with Quality Control, supporting establishment, justification, and extension of product shelf life.
- Exercise strong Quality judgment to identify and escalate potentially critical quality risks.
- Collaborate with internal stakeholders, as well as Rigel vendors and commercial partners, to ensure timely resolution of quality issues.
Change Management
- Lead Quality review and approval of Rigel- and vendor-initiated Change Controls.
- Assess manufacturing, analytical, packaging, labeling, testing, quality system, and supply chain changes for GMP, regulatory, and commercial impact.
- Coordinate cross-functional and partner impact assessments for Change Controls.
- Ensure timely assessment and implementation of approved changes supporting uninterrupted product supply.
- Verify implementation of approved changes during batch disposition.
Batch Disposition & Product Release
- Conduct comprehensive QA review of executed batch records, Certificates of Analysis, Certificates of Compliance, batch genealogy, and other release-supporting documentation.
- Perform Quality disposition of API, drug substance, drug product, and finished goods in accordance with Rigel procedures.
- Partner with Supply Chain and Technical Operations to ensure timely product disposition and availability.
Quality Systems & Compliance
- Serve as a subject matter expert for Rigel's Dot Compliance EDMS/EQMS.
- Create, route, review, approve, and maintain controlled GMP documents in Dot EDMS.
- Support inspection readiness, Health Authority inspections, and partner audits.
- Conduct QA review of regulatory submissions such as annual reports, IND/IMPD and amendments and other regulatory documents
- Support continuous improvement initiatives that strengthen operational Quality Systems.
KNOWLEDGE AND SKILL REQUIREMENTS: - Bachelor's degree in a scientific, technical, or related discipline.
- Minimum eight years of progressive GMP Quality Assurance experience within the pharmaceutical, biotechnology, or life sciences industry.
- Demonstrated experience supporting commercial manufacturing in an outsourced CDMO environment.
- Hands-on experience with batch disposition, batch record review, deviation investigations, Change Controls, and CAPA management.
- Working knowledge of applicable cGMP regulations and FDA, EMA, and ICH requirements.
- Experience supporting Quality Assurance for Quality Control, including analytical investigations, specifications, methods, and laboratory documentation.
- Experience with electronic Quality Management Systems (e.g., Dot Compliance, Veeva, MasterControl, or equivalent).
- Strong investigation, risk assessment, decision-making, and problem-solving skills.
- Excellent communication, collaboration, organizational, and project management skills.
COMPENSATION AND BENEFITS: The anticipated salary range for this position is National $158,000 to $190,000 and, if applicable, Premium Market (SFBA/NYC/Boston Area) $175,000 to $210,000. The actual salary offered will depend on several factors, including experience, qualifications, geographic location, internal equity, and business needs.
This position is eligible to participate in Rigel's annual bonus program and is eligible for equity incentive awards, subject to the terms of the applicable plans. This position is not commission-based.
Rigel offers eligible employees a comprehensive benefits package, including medical, dental, and vision coverage; life and disability insurance; flexible spending accounts; a 401(k) plan; paid time off; paid company holidays; 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.
