Director, Clinical Quality Assurance

Company Description

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 Director of Clinical Quality Assurance will lead the Clinical QA function and provide strategic leadership and operational oversight across global early to late-stage clinical programs. The role is responsible for the development, implementation and oversight of quality policies, procedures, and risk-based systems appropriate for advancement of clinical programs. This individual will ensure compliance with global regulatory regulations, as applicable. The successful candidate will work closely with Clinical Development, Clinical Operations, Regulatory Affairs, and third-party Contract organizations to prepare the team for BLA/BIMO milestones. An in-depth understanding of global Health Authority requirements, clinical program management, quality systems, validation, and data integrity are essential requirements of the role.

Job Description

• Ensure compliance with all applicable local and global clinical regulations.
• Develop and execute a clinical QA strategic vision aligned to corporate and program goals.
• Serve as the senior Clinical QA representative on program and study teams.
• Provide hands-on leadership to develop, implement phase appropriate clinical quality systems, processes, SOPs and governance structures.
• Review and provide QA input on clinical study-specific documentation.
• Collaborate closely with Clinical Development, Clinical Operations, Pharmacovigilance, and Contract service partners to advance clinical programs to late-stage regulatory milestones.
• Provide compliance direction on investigations into significant quality issues related to GCP elements, product handling, administration, or safety. Facilitate identification of root cause, and development of effective corrective and preventive actions. Ensure reporting of potential or confirmed violations to regulatory authorities in collaboration with Clinical Operations, Regulatory and Quality leadership.
• Identify and escalate compliance risks, recommending mitigation plans to Clinical Development and Quality leaders.
• Coordinate with cross-functional stakeholders to mature clinical and GCP training programs.
• Execute a risk-based vendor audit program covering internal, vendor and clinical site audits.
• Assess audit findings for impact on subject safety, data integrity, and business operations, and ensure timely CAPA development and closure.
• Lead GCP inspection readiness initiatives, including mock BIMO interviews, inspection preparedness plans, and cross functional training.
• Manage BIMO sponsor inspections and provide oversight/support for CRO inspections.
• Develop performance-based quality metrics and trend analyses to drive continuous improvement.
• Lead, mentor and develop Clinical QA personnel effectively scaling the team to support late-stage clinical programs.
• 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.
  

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, or a related discipline
• 12 years of relevant experience in Clinical Quality Assurance in the pharmaceutical industry.
• 5 years of prior leadership experience.
• Expert knowledge of global GCP regulations and guidance documents including but not limited to:
• 21 CFR Parts 11, 50, 54, 56, 312
• EU Clinical Trial Regulatory (EU-CTR)
• ICH E6(R2/R3), ICH E8
• General Data Protection Regulation (GDPR)
• Good Clinical Laboratory Practice (GCLP)
• Extensive experience with regulatory inspections, vendor qualifications, vendor audits, and internal audits.
• Experience over a broad set of Clinical Quality Assurance functions with extensive knowledge of industry best practices and trends.
• Ability to understand business objectives and how they translate into quality priorities.
• Late-stage clinical and/or commercialization experience is a plus.
• 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 contract/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 $200,000-$220,000. 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.