Job Title: Associate Director of Supplier Quality

Job Description

Lead supplier quality management and manage the existing supplier lifecycle management program. Oversee vendor audit planning and execution utilizing a risk-based process. Oversee supplier performance and quality data sources, and metric reporting to identify quality issues and trends. Oversee contract manufacturer (CMO) production processes through internal batch release to ensure timely closure of external quality events and product availability. Own and resolve supplier-related CAPAs relating to non-conforming materials and services to identify true root causes and drive timely closure with suppliers. Oversee and run the supplier change management program.

Responsibilities

• Lead supplier quality management and manage the existing supplier lifecycle management program.
• Oversee vendor audit planning and execution utilizing a risk-based process.
• Monitor supplier performance and quality data sources, and metric reporting to identify quality issues and trends.
• Oversee CMO production processes through internal batch release to ensure timely closure of external quality events and product availability.
• Own and resolve supplier-related CAPAs relating to non-conforming materials and services to identify true root causes and drive timely closure with suppliers.
• Oversee and run the supplier change management program.

Essential Skills

• Quality assurance
• Quality management
• Supplier quality
• Supplier management
• CMO
• Quality Management
• Supplier Quality Management
• CMO
• Supplier Change Management
• SAP
• Supplier change management
• SAP
• GMP

Additional Skills & Qualifications

• Requires a BS degree in a scientific discipline
• Minimum of 8-10+ years of experience in Supplier Quality Management within the Pharmaceutical, Biotech, and/or Medical Device industry.
• Knowledge of cGMP requirements by FDA, EMA, ICH Q8, 9, and 10.
• Experience with SAP S/4HANA
• Experience with supplier change management

Work Environment

You will work Monday to Thursday onsite, and Friday will be remote. The work schedule is Monday to Friday, 9:00 am to 5:00 pm in a business casual environment. Strong leadership skills and excellent communication are essential for this role.