Senior Manager, Quality Assurance Vendor & Audit Management

The role

This person will lead vendor qualification, supplier oversight, and GxP audit programs. They will oversee the lifecycle management of suppliers, CMOs, CROs, laboratories, and other GxP service providers.

What you will do

• Lead qualification, approval, requalification, and monitoring of GxP vendors and suppliers
• Develop and maintain risk-based vendor management processes and procedures
• Perform supplier risk assessments
• Oversee vendor performance monitoring including quality metrics and CAPAs
• Maintain the Approved Vendor List
• Develop and execute annual risk-based internal and external audit programs
• Manage audits of CMOs, CROs, logistics providers, treatment centers, and distributors
• Manage vendor records in Veeva
• Support development and review of Quality Agreements
• Lead, mentor, and develop QA Compliance professionals

Required qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biological Sciences, Engineering, or related discipline
• Minimum of 8-10 years in Quality Assurance
• 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

Benefits

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

About the company

Genetix Biotherapeutics is pursuing curative gene therapies. The company is composed of doers, thinkers and collaborators who embrace values of innovation, diversity, and radical care.