Senior Manager, Quality Assurance Vendor & Audit Management

Position Description

The Senior Manager, QA Compliance - Vendor & Audit Management is responsible for leading the Genetix's vendor qualification, supplier oversight, and GxP audit programs to ensure compliance with applicable regulatory requirements, industry standards, and company procedures. This role oversees the lifecycle management of suppliers, contract manufacturing organizations (CMOs), contract research organizations (CROs), laboratories, treatment centers, and other GxP service providers. The individual develops and maintains a risk-based audit strategy, drives supplier quality improvements, and supports inspection readiness across the organization.

Job Duties and Responsibilities

Vendor Qualification & Oversight

• Lead the qualification, approval, requalification, and monitoring of GxP vendors, suppliers, CMOs, CROs, laboratories, distributors, and service providers.
• Develop and maintain risk-based vendor management processes and procedures.
• Perform supplier risk assessments to determine qualification requirements and audit frequency.
• Oversee vendor performance monitoring, including quality metrics, complaint trends, deviations, CAPAs, and service level performance.
• Maintain the Approved Vendor List (AVL) and ensure vendor records remain current.
• Review and approve vendor qualification packages, quality assessments, and associated documentation.
• Partner with Procurement and business stakeholders to ensure supplier selection aligns with company quality requirements.

Audit Program Management

• Develop and execute annual risk-based internal and external audit programs.
• Manage audits of CMOs, CROs, logistics providers, treatment centers, critical suppliers, and distributors.
• Lead or oversee onsite, remote, and hybrid audits.
• Manage Vendor Audit schedule
• Perform initial qualification audits and routine requalification
• Manage vendor records in Veeva
• Ensure audit observations are appropriately documented, classified, and communicated to stakeholders.
• Review and approve audit reports and monitor closure of audit-related CAPAs.
• Evaluate effectiveness of corrective and preventive actions resulting from audits.
• Present audit trends, metrics, and compliance risks to senior leadership.

Quality Agreements Management

• Support development and review of Quality Agreements.
• Ensure agreements clearly define GxP responsibilities between parties.
• Collaborate with Legal, Regulatory Affairs, Technical Operations, and business functions to negotiate quality requirements.
• Track Quality Agreement status and ensure timely renewals and updates.

Regulatory Compliance & Inspection Readiness

• Ensure vendor management and audit programs comply with FDA, EMA, and other applicable regulations.
• Support regulatory inspections and client audits involving vendor qualification and supplier oversight activities.
• Maintain a state of inspection readiness through proactive compliance monitoring.
• Assess emerging regulatory expectations and implement process improvements as needed.

Quality Systems & Continuous Improvement

• Drive continuous improvement initiatives for supplier oversight and audit management processes.
• Develop and monitor key performance indicators (KPIs) and quality metrics.
• Identify systemic compliance risks and escalate significant issues to leadership.
• Support investigations, change controls, deviations, and CAPAs related to suppliers and audit findings.
• Ensure procedures remain current with evolving regulations and industry best practices.

Leadership & People Management

• Lead, mentor, and develop QA Compliance professionals responsible for vendor management and audit activities.
• Establish departmental objectives aligned with corporate quality goals.
• Manage resource planning, budget forecasting, and departmental performance metrics.
• Foster a culture of quality, compliance, accountability, and continuous improvement.

Required Education, Experience, or Qualifications (or equivalent)

Education

• Bachelor's degree in Life Sciences, Pharmacy, Biological Sciences, Engineering, or related discipline and a minimum of 8 -10 years in Quality Assurance is required

Experience

• 8+ years of Quality Assurance, Compliance, Auditing, or Quality Systems experience within Biotechnology, Cell & Gene Therapy, Pharmaceuticals, Medical Devices, or related regulated industries.
• Prior experience managing personnel and compliance programs.
• Extensive experience conducting and managing GxP audits.
• Strong experience qualifying and overseeing CMOs, CROs, laboratories, suppliers, logistics providers, and other regulated vendors.
• Experience supporting regulatory inspections and responding to health authority observations.
• Demonstrated success engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence