Quality Systems Manager / Sr. Manager
Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.
Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.
The <Quality Systems Manager / Sr. Manager> will manage documents (both electronic and paper copies) within Quality Assurance and other key departments at Nurix Therapeutics to ensure that all GXP regulated documents are filed systematically and are easily retrievable. Duties will include management of GXP records, lifecycle management of records, maintenance of the document database, and troubleshooting document issues and requests.
Essential Duties and Responsibilities (including, but are not limited to):
- Oversee the receipt, filing, and maintenance of all GXP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, Product Complaints, computer system validation, etc.
- Design and implement an enterprise-wide document repository that tracks the receipt, revisions and archiving of all GXP documents; and prepare supportive process workflows and procedures to maintain efficiency and access for all users.
- Maintain GXP audit files and assist with entry, tracking, and archiving of audit records.
- Oversee and administer document lifecycle management as well as the Document Change Request process.
- Responsible for the integration of the Learning Management System (Training System) with the new document repository.
- Administration and maintenance of training records and documentation within our Learning Management System.
- Assist with and/or write SOPs for the creation and development of processes, archiving, and operations related to Quality Systems / Document Control.
- Perform review of documents submitted through the change control process for format, completeness, review, and approvals. Issue controlled document copies to internal and externals requestors.
- Process document requests to be used in-house or sent to CSPs in a timely manner.
- Provide guidance and training to staff regarding document control processes.
- Other essential duties as assigned.
- Knowledge of quality systems and regulatory compliance requirements within biopharmaceutical environment.
- Strong EDMS and computer skills to include Excel, Word, Adobe Acrobat, PowerPoint, Visio, DocuSign, and experience in LMS and eQMS systems and administration.
- Attention to detail, critical thinker, and effective organization skills required.
- Strong communication and proficient soft skills.
- Works well in a team environment with the ability to drive results.
- Ability to solve problems and work collaboratively in a team environment.
Education and/or Experience:
- B.S. Degree in a related scientific field desired.
- A minimum of 5 years of experience within the pharmaceutical/biotech field performing document management and electronic document management.