ORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists authority, responsibility, and support to do cutting-edge work on therapies for treatment-resistant cancers. Our culture and values support our mission, provide a shared understanding of how we work together as a company and provide a clear sense of what is most important to us as an organization.

The Quality Assurance Specialist will support the implementation and maintenance of Quality Management System (QMS) processes, ensuring compliance with regulatory requirements across clinical and commercial activities. This role involves assisting with documentation review, quality metrics preparation, training, and inspection readiness efforts. The position supports cross-functional teams in addressing quality risks and compliance issues while contributing to the preparation and release of Clinical Trial Materials (CTMs) and GMP products.

Job Description

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

• Assist in the implementation and maintenance of GXP/non-GXP systems and equipment that support clinical development or commercial activities ensuring compliance with applicable regulatory requirements.
• Support the evaluation, creation, and/or review operating procedures (eg, policies, SOPs, etc.), and other documentation to align with quality management system for a clinical and commercial stage company.
• Participate in the preparation of quality/KPI metrics to support GXP activities and management review.
• Support the compliance with Quality Agreements with cross-functional teams, CDMOs and contract laboratories as identified.
• Ensures Clinical Trial Materials are properly tested and released, by reviewing batch records, Certificates of Analysis (COAs), and associated data for the release of Clinical Trial Materials and GMP products.
• Coordinate, identify, and address quality risks, support resolutions, and ensure mitigation as applicable for cross-functional teams compliance. Work with cross-functional team to ensure support commercial readiness.
• Support the implementation, maintenance, and execution of the Inspection Readiness program and support activities related to readiness scorecard across all GXP functions in all stages of development or commercialization.
• Support the Annual Management Quality Review Program by preparing relevant data and documentation as required.
• Support key Quality Systems as required, including Product Quality Review (PQR) or CAPA process.
• Perform training for cross-functional teams on QMS processes.
• Demonstrates a high level of independent judgment.

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

Qualifications

• 5 years industry experience in a Quality-related position. Bachelor’s degree in a relevant field (or equivalent).
• Experience supporting quality systems for clinical and commercial drug products.
• Working knowledge of GXP Federal Regulations including 21 CFR Part 11 regulations and quality systems.
• Experience quality management programs in the pharmaceutical or biotechnology industry is a plus.
• Knowledge and hands on experience in supporting electronic (GXP) systems such as TrackWise, Intellect, or Veeva is a plus.
• 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.

Additional Information

The anticipated salary range for candidates who will work in our San Diego location is between  $110,000-$125,000. 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 characteristics.