Manager, Quality Assurance(m/w/x)

Description

In this role, you will oversee quality assurance by conducting audits, managing supplier relationships, and ensuring compliance with regulatory standards. Your day-to-day responsibilities will involve collaborating with teams to enhance quality systems and address complex challenges.

Requirements

• •BS or BA with minimum 5 years of Quality Assurance experience
• •In-depth knowledge of GMPs, FDA/EMA regulations and ICH guidelines
• •Strong attention to detail
• •Significant auditing experience or ASQ certification (CQA, CQE) or auditor certification preferred
• •Materials and suppliers’ management experience
• •Excellent verbal, written, and interpersonal communication skills
• •Experience leading and contributing through influence and working in cross functional teams
• •Ability to work in a fast-paced team environment and meet aggressive timelines while prioritizing tasks for multiple projects
• •Ability to adapt to changing priorities
• •Strong overall knowledge of biologics manufacturing processes and Quality Systems

Tasks

• •Perform third-party audits for compliance
• •Lead responses to audit observations and implement CAPAs
• •Collaborate with Global Vendor Management
• •Support the introduction of new suppliers
• •Manage materials through Vendor Change Notifications (VCNs)
• •Establish Quality Agreements and regulatory documentation
• •Represent QA in cross-functional team meetings
• •Review and approve compliance documentation
• •Develop and maintain procedures for supplier management
• •Participate in process improvement projects
• •Engage with stakeholders to resolve complex issues