Senior Manager, GMP Quality Operations

Role Summary

The Senior Manager, GMP Quality Operations is responsible for overseeing day-to-day GMP Quality Assurance operations at Rigel and across contracted manufacturing and testing organizations. This role ensures timely batch record review, product disposition, and adherence to cGMP requirements. It also supports internal readiness for manufacturing campaigns, deviation and CAPA management, and inspection preparation activities in collaboration with QA leadership and cross-functional partners.

Responsibilities

• 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‚Äôs 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.

Qualifications

• 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.

Education

• Bachelor‚Äôs degree in a scientific or technical discipline.

Additional Requirements

• 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.