Director, Clinical Quality Assurance
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Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
- 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 :
- Bachelors or Masters 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
- 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 $200000-$220000. 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.
Remote Work :
No
Employment Type :
Full-time
Key Skills
About Company
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 ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high ... View more
