IT Quality Assurance Manager jobs in San Diego, CA

This position works in conjunction with other Quality team members and will manage day-to-day tactical quality operations related to GMP clinical manufacturing operations and clinical trial drug oversight activities. In addition, the role will support the Pharmaceutical Sciences (PharmSci) GMP campaigns, Quality Assurance (QA) vendor oversight / audits, and broad quality system implementation.

Responsibilities:

• Manage PharmSci related operations (eg, Active Pharmaceutical Ingredient (API)/Drug Product (DP) disposition, stability program, event management, etc) on behalf of the QA Department. Will ensure that FDA and other applicable global regulatory compliance guidelines for API/DP manufacturing, packaging, and distribution are met
• Assist with establishing, expanding, and maintaining ORIC’s GXP compliance program
• Assist Senior QA management with vendor oversight, qualification, and maintenance
• Assist ORIC development teams to ensure proper oversight of vendors and identified quality events
• Evaluate, author, and/or review operating procedures (eg, policies, SOPs, etc), and perform other activities in support of an integrated cross-functional Quality Management System
• Assist in developing reports quality/Key Performance Indicators metrics to support GXP activities and management review
• Liaise with colleagues and vendor to ensure a full understanding of ORIC and regulatory requirements both internally and externally
• May serve as QA Lead for assigned clinical stage programs, ensuring balance between operational timelines and compliance requirements
• Ensure Clinical Trial Materials are properly tested and released, including review of batch records, Certificate of Analysis, and associated release data of GMP products
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Experience:

• 5-7 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 with internal and external auditing 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 cGMP, ISO standards 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