Associate Director, Quality Assurance

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 the 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.

Job Description

Directs and implements ORIC quality function and is responsible for planning quality policies, programs, and initiatives. Requires extensive experience and track record of judgment, project planning and accomplishing goals within a regulatory framework. Has experience implementing and maintaining all aspects of Quality System Regulation (QSR). Performs a variety of tasks while directing the work of others as either direct reports or as a member of a broader cross-functional team. Along with broad quality system implementation and support, the role will include focus on program development, clinical trial functions and GMP clinical and commercial manufacturing.

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

• Manage the tactical operations of a team of Quality Assurance professionals with responsibility for performance evaluation, development and resource management.
• Implement and update, as applicable, the electronic Quality Management System. Ensure the system complies with applicable regulatory requirements.
• Ensure company compliance with GLP, GCP and GMP as required. Evaluate the QA metrics control systems for continuous improvement and ease of use.
• Coordinate, identify, and address issues and risks, drives resolution, and escalates to ensure timely resolution.
• Manage the Vendor/Supplier and Audit Programs.
• Manage the implementation, maintenance, and execution of the Inspection Readiness program, including the creation of an inspection readiness scorecard across all GXP functions; including setting the strategic plan for maintaining organizational inspection readiness across multiple projects in all stages of development or commercialization.
• Lead the Annual Management Quality Review Program. Control key Quality Systems as required, including Annual Product Quality Review (APQR) or CAPA process.
• Operate as a Single Point for Contact (SPOC) in managing an end-to-end timeline of review and release of clinical material and commercial products. Ensure all inputs and outputs within and from GMP Quality are timely and compliant with commitments.
• Manages both functional and cross-functional GMP Quality metrics across groups, (ie, Drug Substance, Drug Product/Finished Goods, Clinical, Lot Disposition, Partner Management).
• Coordinates across clinical and commercial GMP Quality product groups to assure alignment and escalates issues and risks which impact deliverables.
• Partners with Supply Chain to align on supply forecasts. Ensures timelines are met with Right First-Time principles for clinical trial material and commercial review and release.
• Demonstrates a high level of independent judgment.

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

Qualifications

• 7+ years industry experience in quality-related position. BS Degree in relevant field (or equivalent)
• Ability to develop and implement quality systems for clinical and commercial drug products.
• Experience with FDA related QSR implementation. (Not required but a plus.)
• 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 managing 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.

Additional Information

The anticipated salary range for candidates who will work in our South San Francisco location is between $103,000-$152,000. 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.