Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.
Purpose:
The Senior Manager Quality Assurance Operations will support the quality operations and support compliance activities of in its product development and commercialization efforts. This person will work closely with the company's CMC group assuring accurate and timely flow of information including, but not limited to: specifications, batch records, and product release for APIs and drug products, in compliance with company standards and cGMP procedures. The person will support Regulatory filings and inspections. They will work closely and support the Quality Management Systems (QMS) personnel. This position reports to the Director of Quality.
Responsibilities:
The job responsibilities are:
- Drug Manufacturing
- Develop and maintain essential quality systems for both development and commercial environments, including document control (including SOPs), exception management, change control, CAPA, training, validation, and auditing.
- Participation in CMO selection, commissioning, qualification and certification.
- Negotiation of quality agreements with contract manufacturers.
- Approval of development, transfer, master and study specific validation protocols and reports.
- Verification of process data and approval of technical protocols, reports, and chemistry, manufacturing and control sections of regulatory submissions.
- Approval of production related activities via approval of: specifications, master batch records, change controls, sampling and testing plans, stability study protocols and reports.
- Leading deviation and out of specification investigations.
- Review of executed batch records and releasing API batches, certifying compliance with regulatory commitments/filings.
- Support filing of Quality documents in Dot Compliance
- Quality Auditing:
- Support QMS function in domestic and international audits of contract manufacturers, participating cross functionally with internal stakeholders to assure compliance with GMP regulations and Nurix Standards Operating Procedures (SOPs).
- Support internal quality audits to assess Nurix’s GMP compliance.
- Communicating audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop root cause Corrective and Preventive Action (CAPA) plans.
- Maintaining databases for audit observations and CAPAs.
- Tracking, reviewing, approving, and assessing the effectiveness of CAPAs.
- Competent Authority Inspections:
- Facilitate and assist with the preparation, coordination, and management of Competent Authority inspections of Nurix and contract manufacturers.
- Prepare contract manufacturers for Competent Authority GMP inspections, including pre-approval inspection.
The position will require interaction with senior management and executives on matters concerning the quality of products and contractor compliance. The incumbent is expected to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. They will be expected to exercise judgment within broadly defined regulations in selecting systems and evaluation criteria for obtaining results. They will support budgets, schedules, and performance requirements are met.
Qualification Requirements:
- Minimum of BS/BA in chemistry or related scientific field
- Minimum of 5 years of progressive quality assurance experience in clinical or commercial pharmaceutical operations and development; experience in both development and commercial operations required
- Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards
- Strong proven hands-on experience with GMP compliance matters and contractor management in the bio/pharma industry. Knowledge of GLP and GCP plus
- Experience working with contract manufacturers
- Experience with the regulatory submission and approval process
- Strong knowledge of QA systems and company-wide SOP systems for all phases of clinical development
- Understanding scientific methods and the ability to interpret and communicate scientific data internally and externally
- Independent and self-directed
- Excellent communication and organizational skills
- Proficiency with eCTD software, document management systems, review management/version control software (eQMS systems), Microsoft Office and Adobe Acrobat
- Ability to travel as much as 50% or as required.
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 travel domestically and internationally.
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