Manager, Safety Quality and Compliance - Remote

Overview

The Manager, Safety Quality and Compliance will be responsible for supporting the development, management and oversight of processes, systems and PV inspection preparedness activities pertaining to safety and pharmacovigilance to ensure PV compliance with global regulations. This role will be key in contributing to process improvement, inspection readiness, internal/partner audits, and global regulatory inspections to drive compliance, building training model, supporting PV related agreements. This role also includes partnering with PV Operations to provide safety operations support as needed, manage and monitor internal PV activities and external oversight of CROs and vendors providing PV related services to Arcus.

In Short

• Support impact assessment of existing PV processes when there are changes to regulatory requirements.
• Collaborate on the preparation and revision of Standard Operating Procedures (SOPs).
• Coordinate document review with applicable internal and external stakeholders.
• Support the preparation and compliance oversight for safety data exchange agreements.
• Provide vendor management and oversight activities.
• Lead/co-lead PV audits and inspections.
• Conduct audit/inspection preparedness activity and risk assessment.
• Prepare/review audit/inspection agenda and plan.
• Monitor action items for all stakeholders involved in a PV audit/inspection.
• Manage quality events/deviations and CAPA activities related to safety reporting.

Requirements

• Bachelor’s degree in nursing, pharmacy, or related field.
• 4+ years in the pharmaceutical industry; 2+ years in Safety and Pharmacovigilance.
• Oncology experience is required.
• Experience in safety quality systems and compliance monitoring.
• Strong knowledge of drug safety database systems and QC tools.
• Expert knowledge of FDA, EMA, Asia-PAC, and ICH regulations.
• Strong problem-solving and critical thinking skills.
• Excellent communication and organizational skills.
• Ability to work in a dynamic, fast-paced environment.
• Strong project management experience.

Benefits

• Opportunity to work in a dynamic environment.
• Engagement in significant process improvement initiatives.
• Collaboration with cross-functional teams.
• Support for professional development and training.
• Participation in global regulatory inspections.
• Flexible work arrangements (office or remote).
• Competitive salary and benefits package.
• Commitment to equal opportunity employment.
• Supportive team culture.
• Opportunities for career advancement.