Quality Assurance Document Control Associate

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer.  ORIC’s clinical stage product candidates include ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers, and ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer.  Beyond these product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms.  ORIC has offices in South San Francisco and San Diego, California. 

This position works in conjunction with other Quality team members and is responsible for the tactical oversight and maintenance of the Quality Management System (QMS) for ORIC internal and external activities. This includes establishing continuous improvement and ensuring consistent implementation of global quality system policies across the GXP spectrum. In addition to quality system implementation and support, the role will assist in oversight of training activities for GMP personnel within the QMS environment.

Essential duties and responsibilities include the following. Other duties may be assigned.

• Act as System Administrator by managing, providing support and troubleshooting for ORIC’s electronic Document Management System (eDMS)/Learning Management System (LMS).
• Support implementation and migration activities of ORIC eDMS/LMS modules.
• Assist with company training program and maintenance of training records.
• Provide user assistance and training on document control, quality, and training management systems, processes, and procedures
• Manage eDMS, including performing document review, approval/release and archiving activities.
• Assist with establishing, expanding, and maintaining ORIC’s GXP compliance program.
• Evaluate, author, and/or review operating procedures (eg, policies, SOPs, etc.), and perform other activities in support of an integrated cross-functional QMS.
• Work closely with other Quality team members to ensure cross-functional implementation of quality management system (Deviations, Investigations; CAPA; Product Complaints; Change Control) ensuring compliance with applicable regulatory requirements.
• Assist with internal audit program and audit schedule. May assist with performance of both internal and external audits.
• Assist in developing reports quality/Key Performance Indicators (KPI) metrics to support GXP activities and management review.
• Lead tactical records management operations on behalf of the Quality department, ensuring compliance and retention as applicable with regulatory requirements.

Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

• 1-3 years of progressively responsible industry experience in a quality-related position. BS Degree in relevant field (or equivalent)
• Working knowledge of GXP Federal Regulations including 21 CFR Part 11 regulations.
• Experience quality management programs in the pharmaceutical or biotechnology industry is a plus.
• Knowledge and hands on experience in managing electronic (GXP) systems such as TrackWise, Intellect, or Veeva is a plus.
• Knowledge of GXP regulations and quality systems.
• Effective oral and written communication skills. Strong interpersonal skills. Ability to successfully solve challenging issues, perform critical thinking, and be detail oriented.

Excellent organizational ability – can easily multitask and shift priorities as needed. Ability to think and plan strategically 

The anticipated hourly range for candidates who will work in our San Diego location is between  $60,000-$85,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc. 

ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristic.