Senior Manager, Clinical Quality Assurance - Remote

Overview

The Senior Manager, Clinical Quality Assurance is responsible for working with study management teams to facilitate internal and external adherence to Quality and Regulatory Compliance by ensuring conformance to domestic and international quality regulations and GCP guidelines.

In Short

• Support clinical study teams as a core team member for assigned studies.
• Identify and escalate serious non-compliance issues to Clinical QA and Quality group leadership.
• Maintain a high level of expertise in global GCP regulations and internal policies.
• Act as Clinical QA point of contact for specific clinical functional areas.
• Support the management of study-specific deviations/events/CAPAs in the GCP/PV space.
• Collaborate with CRO quality counterparts as delegated.
• Participate in internal and external GCP audits as assigned.
• Maintain up to date audit execution results in electronic quality management systems.
• Clearly present audit findings to appropriate departmental personnel.
• Work with auditees to ensure completion of corrective and preventative actions.

Requirements

• Bachelor of Science/ Bachelor of Art in a relevant discipline required (Biological or Life Sciences preferred).
• 6+ years in pharmaceutical drug development in Clinical Quality Assurance and/or GCP-related discipline.
• Previous experience which provided the knowledge, skills and abilities to meet the expectations outlined in this job description.
• Quality Auditor / Manager certification preferred.
• Excellent working knowledge of ICH Guidelines and GCP regulations.
• Experience leading audits of GCP/GCLP/GPvP vendors and internal audits.
• Experience managing inspection readiness activities and supporting health authority inspections.
• Ability to build and maintain positive relationships with colleagues.
• Self-motivated with the ability to manage multiple responsibilities.
• Excellent oral and written communication skills.

Benefits

• Competitive market-based salary.
• Participation in stock programs.
• Performance-based bonus.
• Comprehensive benefits package.
• Opportunity for growth in a dynamic environment.