Senior Director, Quality

• Ensure compliance with all applicable local and global drug regulations.
• Oversee Quality CMC functions with oversight and authority over batch disposition, manufacturing, packaging, labeling and testing activities to ensure product quality and timely release of materials and products.
• Provide hands-on leadership to effectively facilitate quality functions related to batch disposition, investigations, process and analytical data review, supply distribution and risk management.
• Serve as a point of contact for complex or high-risk quality issues and decisions.
• Identify and manage quality risks across the product life cycle, recommend and support mitigation strategies.
• Operate closely with ORIC technical operations team, Contract Manufacturing Organizations (CMOs), contract testing laboratories, and distribution sites to facilitate quality review of process/analytical data and reports, ensuring technical rigor and phase appropriate compliance to support program decisions.
• Work cross-functionally with Regulatory Affairs to ensure timely and accurate review of submissions.
• Operates closely with clinical program teams and serves as an active participant in clinical development meetings ensuring continuous quality support.
• Develop performance-based quality metrics and trend analyses to drive continuous improvement.
• Perform and present Annual Product Reviews for late-stage programs.
• Lead, mentor and develop a high-performing Quality team effectively scaling the team to support clinical into commercial programs.
• Serve as Chair or primary Quality member in various governance committees including ORIC’s Stability Review Board, Material Review Board and Change Review Board
• Represent ORIC Quality in CDMO meetings, regulatory authority interactions, strategic leadership meetings as needed.
• Demonstrate a high level of adaptability in dynamic and fast-paced environments. This includes the ability to adjust strategies, workflows, and priorities in response to changing business needs, technologies, and stakeholder expectations.
• Develop new functional, late phase, commercial ready SOPs, Policies/Plans as necessary.

Qualifications

• Bachelor’s or Master’s degree in Chemistry, Biology, or a related scientific discipline
• 15+ years of relevant experience in Quality Assurance and/or Quality Control in the pharmaceutical industry.
• 7+ years of prior senior leadership experience.
• Deep hands-on knowledge in ICH, GMP, and regulatory guidance relevant to new drug development and commercialization. Experience with preparing for commercial stage operations and regulatory interactions preferred.
• Experience over a broad set of Quality Assurance functions with extensive knowledge of industry best practices and trends.
• Ability to understand business objectives and how they translate into quality priorities.
• Demonstrated ability to develop a vision for Quality functions as it transitions through the phases of drug development to commercialization.
• Demonstrated success in working with and managing CDMOs and external partners using succinct and thorough communication skills.
• Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work.
• Demonstrated initiative, ownership, problem identification, problem solving, and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met.
• Results driven, collaborative leader with proven ability to perform in a fast-paced environment with a high attention to detail and demonstrated ability to manage and prioritize multiple competing tasks
• Excellent verbal and written communication skills, with the ability to build productive long-term team relationships at all levels of supplier organizations, including with senior executives
• Skilled at managing autonomous, high-performing professionals who value flexibility, while ensuring alignment, collaboration, and delivery of results.

Additional Information

The anticipated salary range for candidates who will work on-site at our San Diego location is between $220,000-$270,000. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors.

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.