Senior Director, Quality

ORIC Pharmaceuticals•San Diego, CA

5d•$220,000 - $270,000•Onsite

About The Position

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com , and follow us on X or LinkedIn . Reporting to the Senior Vice President of Quality, the Sr. Director of Quality will lead provide quality oversight of clinical development and manufacturing programs. This individual will lead the Chemistry, Manufacturing, and Controls (CMC) QA team and provide end-to-end development to manufacturing support for clinical stage programs and will develop systems to commercialize late-stage assets. This position will design, develop, and implement clinical and commercial quality strategies to ensure appropriate compliance to applicable regulatory regulations. The successful candidate will work closely with Technical Operations, Regulatory Affairs, and third-party Contract Development and Manufacturing Organizations (CDMOs) and will be responsible for all levels of studies, ranging from simple to complex and requires an in-depth understanding of GMPs, global Health Authority requirements, program management, quality systems, validation, and data integrity. Strong cross-functional team leadership and project management skills are essential requirements of the role.

Requirements

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 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.

Nice To Haves

Experience with preparing for commercial stage operations and regulatory interactions preferred.

Responsibilities

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.