QA Program Manager - Quality Systems

Your Tasks

• Develop metrics for Quality Systems in support of management review and various quality reports
• Assist with creation of shared Quality Systems documents for Bachem Americas sites to achieve harmonization
• Assist with implementation of different modules of Master Control software at Bachem US
• As part of the Central Function Quality System team you may be required to assist with maintenance/oversight of some of the following Quality Systems:
• Quality Event Reporting
• Document Management System
• Change Control/Equipment Change Control
• Data integrity program
• Supplier Quality program
• Material Qualification Program 
• Internal audit program
• External audit program
• Annual Product Review

Your Profile

Required:

• Bachelor’s Degree in a science related field – Chemistry, Biology or equivalent
• Minimum of 5 to 8 years of experience in quality assurance
• Extensive experience in cGMP manufacturing, Quality Control, or Quality Assurance
• Experience in writing standard operating procedures, specifications and technical reports
• Experience conducting audits
• Experience with the Material Qualification process
• Experience in developing quality system metrics
• Technical writing experience
• Excellent written and oral communication skills
• Excellent computer skills, including Microsoft Word, Excel and PowerPoint and Access
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Ability to interact well with co-workers, customers, regulatory agency auditors and senior management
• Communicate effectively and ability to function well in a team environment

Preferred:

• Master’s Degree in Science related field
• Experience with Master Control or other electronic quality management system
• Lean or six-sigma Green and/or Black belt certification