- 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
- 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.
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Quality Assurance Manager - San Diego, United States - ORIC Pharmaceuticals Inc
Description
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:
The anticipated salary range for candidates is between $121,500-$148,500. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC is a multi-state employee, and this salary range may not reflect positions that work in other states.
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.
