Senior Manager, Clinical Quality Assurance

Location: San Carlos, California, United States; hybrid with a minimum of 3 days per week onsite or remote. Travel up to 15% may be required.

Salary: $163,000–$191,000 per year for the San Francisco Bay Area; ranges may vary for non-California locations.

Company

hirify.global delivers healthcare solutions with a focus on clinical quality and regulatory compliance.

What you will do

• Lead global investigations and support teams with CAPA preparation in accordance with regulations, guidelines, customer requirements, SOPs, and project instructions.
• Manage quality issue and serious breach investigations, including review and approval of RCA, CAPA, and effectiveness check plans.
• Track quality events from issues, audits, and inspections through closure and oversee updates in the eQMS.
• Plan, schedule, and conduct risk-based and for-cause audits of clinical investigator sites, CROs, and other GCP vendors.
• Support regulatory inspection readiness through mock inspections, gap assessments, and inspection response coordination.
• Evaluate policies and procedures, recommend process improvements, and promote quality excellence across clinical activities.

Requirements

• Bachelor’s degree in a related field.
• At least 9 years of quality assurance experience in the clinical or pharmaceutical industry; equivalent combinations of education and experience may be considered.
• Experience across all phases of clinical development and knowledge of applicable FDA regulations and ICH guidelines.
• Knowledge of quality management systems and QA tools; Veeva experience is preferred.
• Strong communication, collaboration, analytical, problem-solving, and attention-to-detail skills.
• Ability to work in the San Carlos, California hybrid arrangement with at least 3 onsite days per week, or under the approved remote arrangement.

Nice to have

• GCP QA certification, such as RQAP-GCP or similar.
• Experience with Veeva quality management systems and QA software.

Culture & Benefits

• Comprehensive benefits package.
• Equity component.
• Hybrid or remote work arrangement, subject to business needs, job responsibilities, and company policy.
• Opportunity to contribute to quality initiatives and continuous process improvements.