Small Molecule CMC QA Director

Location
San Francisco, CA, United States
Posted
Mar 11, 2021
Ref
5130805002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Company:

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.

Job Summary:

Candidate will provide a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, track appropriate training, proper change control process, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet regulatory standards. The successful candidate will be required to make difficult decisions which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas. The successful candidate will be responsible for implementing continuous improvement efforts as it relates to QA activities and fostering quality collaboration among partners and internal customers.

Responsibilities:
  • Responsible for both executing and overseeing the tactical operations, assess, evaluate, and review operations against cGMPs, issue identification/ resolution including proper and timely documentation. Provide guidance to all GMP areas to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business.
  • Identifies, classifies and reports deviations, as appropriate and typically works on complex Major deviations and/or complaints. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
  • Ensures that all personnel engaged in GMP/GLP activities are properly trained, and the training is appropriately documented
  • Will communicate with clients, external vendors, external services to resolve investigations as warranted to ensure compliance to regulations and local procedures.
  • Responsible for providing quality oversight to the change management system. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.
  • Performs independent technical review of documentation during and post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved and Approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings to appropriate departments.
  • Works closely with others in the assigned area to recognize opportunities for improvement and drive change.
  • Will serve as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and is significantly involved in inspections by regulatory agencies.
  • Models effective and constructive communication behaviors and interactions with technical departments, senior business leaders, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g. interpersonal) skills.
  • Is proficient in technical and non-technical (e.g. interpersonal) skills to ensure the continued success of the department and quality of oversight provided to the business.
  • Creates and establishes processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations.

Requirements:
  • Requires a bachelor's or higher degree from an accredited institution preferably in sciences.
  • Requires a minimum of twelve (12) years of experience working in the Quality aspects at a pharmaceutical or biopharmaceutical company, preferably with a focus on small molecules .
  • Must have demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.
  • Strong independent judgment and decision-making abilities required.
  • Thorough knowledge of relevant regulations and guidances required in order to act as a resource for colleagues.
  • Proven project-management skills required. Must be able to manage multiple projects against given timelines.
  • Demonstrated hard-working and productive work ethic in an ambiguous environment strongly preferred.
  • Proven problem-resolution skills required
  • Possesses strong conflict resolution and negotiation skills
  • Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
  • Must possess excellent verbal and written communication skills; outstanding interpersonal skills.
  • Must have experience ensuring respectful interactions with individuals with diverse views or backgrounds.
  • Ability to work independently.
  • Some travel to CDMO sites may be required, to perform Quality oversight activities