Rigel Pharmaceuticals Inc. · 2 days ago
Senior Manager, GMP Quality Operations
South San Francisco, CA
Full-time
Onsite
Senior Level
$170K/yr - $205K/yr
7+ years expRigel Pharmaceuticals Inc. is a biopharmaceutical company focused on developing innovative therapies. The Senior Manager, GMP Quality Operations is responsible for overseeing GMP Quality Assurance operations, ensuring compliance with cGMP requirements, and supporting manufacturing readiness and quality management activities.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Execute GMP QA operations associated with Make-Assess-Release steps enabling un-interrupted supply of quality product to patients
Provide QA support for production campaigns, approve master production records, specifications, sampling plans, and analytical method documents
Lead Rigel product release program for commercial and clinical products (API, Drug Substance, Drug Product, Bright Stock, Finished Drug Product, and Professional Samples)
Ensure manufacturing and testing activities at contract organizations are performed in compliance with cGMP standards
Lead Rigel Quality Event program to ensure effective investigation and resolution. Define and enforce investigation standards, ensuring investigations are comprehensive, timely, and compliant with regulatory requirements
Lead Rigel CAPA program to ensure appropriate steps are taken to correct/prevent recurrence of quality issues. Measure CAPA effectiveness and ensure CAPA actions are completed timely
Support implementation and continuous improvement of Rigel’s Quality Management System (QMS)
Partner with Supply Chain and Manufacturing to ensure readiness for manufacturing and product launch activities
Provide QA oversight for Rigel stability programs, support shelf-life establishment and extensions
Support internal and external inspections, ensuring documentation and records are audit-ready
Develop and track operational quality metrics (e.g., deviation closure rate, release timelines)
Mentor Technical Operations staff on quality topics, fostering a culture of quality and operational excellence
Qualification
Required
Bachelor's degree in a scientific or technical discipline
7+ years of progressive experience in pharmaceutical GMP Quality Assurance
Strong knowledge of FDA and EMA cGMP regulations and guidance
Experience managing QA operations within CDMO environments
Experience with small molecule manufacturing (tablets and capsules dosage forms)
Experience QA oversight labeling/packaging activities and label creation/revision process
Excellent leadership, communication, and collaboration skills
Demonstrated ability to prioritize and manage multiple concurrent activities
Proficiency in electronic quality systems (EQMS) and document control tools
Company
Rigel Pharmaceuticals Inc.
Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders and cancer.
51-200 employees
H1B Sponsorship
Rigel Pharmaceuticals Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$192.5MKey Investors
U.S. Department of DefenseMPM Capital
2021-01-29Grant· $16.5M
2011-05-27Post Ipo Equity· $130M
2010-01-01Post Ipo Equity
Leadership Team
Raul R. Rodriguez
President and CEO
Dean Schorno
CFO
Recent News
2025-12-07
Company data provided by crunchbase