Vendor Jobs

About The Position

Requirements

• 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
• 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

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• comprehensive health, life and disability insurance
• employer-matched 401(k) plan
• lifestyle spending account
• flexible time-off + paid holidays and winter holiday period
• tuition reimbursement & loan repayment assistance
• paid parental leave
• paid onsite parking
• commuter subsidy