Senior Manager, Clinical Quality Assurance

This is a fully remote position, open to applicants in California.

📋 Description

• Collaborate with clinical study teams as a key member through study management meetings, review of study documentation, and provide GCP-related QA consultation.

• Recognize and escalate significant non-compliance matters, including the evaluation of serious breaches.

• Maintain a thorough understanding of global GCP regulations and internal policies relevant to the conduct of clinical studies.

• Act as the Clinical QA liaison for designated clinical functional areas and projects.

• Assist in the management of study-specific deviations, events, and CAPAs within the GCP/PV domain.

• Work in tandem with CRO quality counterparts, including engaging in QA-QA meetings.

• Participate in both internal and external GCP audits and oversee assigned audit lifecycle activities, which encompass scheduling, planning, agenda creation, execution, reporting, response evaluation, CAPAs, and closure.

• Document audit execution results in Arcus’s electronic quality management system, preferably Veeva Quality Vault, and monitor compliance trends.

• Present audit outcomes and pertinent information to departmental staff.

• Collaborate with auditees to finalize corrective and preventive actions.

• Assist in QA activities during partner audits and regulatory inspections.

• Engage in inspection readiness and pre-approval inspection preparations with study teams, functional areas, partners, and CROs.

• Promote strategic quality and compliance process enhancement initiatives.

• Conduct audits of investigator sites, internal functional/process areas, and clinical vendors (GCP, GCLP, GPvP).

• Facilitate Investigator Site Audits.

⛳️ Requirements

• A Bachelor of Science or Bachelor of Arts in a relevant field is required; a degree in Biological or Life Sciences is preferred.

• Minimum of 6 years of experience in pharmaceutical drug development within Clinical Quality Assurance and/or GCP-related fields.

• Quality Auditor/Manager certification is preferred.

• Strong understanding and ability to interpret ICH Guidelines along with domestic and international GCP regulations.

• Proven experience in leading audits for GCP/GCLP/GPvP vendors, investigator sites, and internal clinical functional areas.

• Experience in managing inspection readiness activities and supporting inspections from FDA, EMA, and other health authorities.

• Skill in building and sustaining positive relationships throughout the organization.

• Self-driven; capable of taking initiative, assuming ownership, and juggling multiple responsibilities within tight deadlines.

• Exceptional customer-service focus and a high level of professionalism.

• Ability to operate with minimal supervision.

• Strong oral and written communication abilities.

• Competence to work in a standard office environment and utilize standard office equipment, including computers.

• Capability to lift, carry, push, and pull materials and objects weighing up to 25 pounds.

🏝️ Benefits

• Stock programs

• Performance-based bonus

• Comprehensive benefits package