Sr. Manager - QA Incoming Batch Disposition

Role Summary

Sr. Manager - QA Incoming Batch Disposition. Responsible for support of the quality disposition of materials, semi-finished and finished goods for the RTP production site, building a strong quality culture, and oversight of ongoing operations, site inspection readiness, and execution.

Responsibilities

• Support the site to ensure a safe work environment including leading safety efforts for the team
• Foster a strong quality culture through open communications, teamwork, and employee participation
• Assist in developing the site operational readiness plan and quality processes, and approve operational procedures
• Build a diverse, capable organization to support quality oversight and ensure compliance with area procedures for material and product record review and release
• Drive operational excellence in disposition processes through data analysis to reduce variability and align cycle times with supply targets
• Supervise, coach, develop, and manage performance; maintain a fair and equitable work environment
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Support site inspection readiness and execution
• Collaborate with area process teams for metrics reviews, operational support, and deviation management
• Coordinate activities with project and functional areas to support overall project and site schedule
• Set area HR and business plan goals

Qualifications

• Required: Bachelor's degree in a science, engineering, computer, pharmaceutical-related field or equivalent experience
• Required: Experience in pharmaceutical QA/QC roles
• Required: Management or leadership experience with cross-functional collaboration
• Required: Legally authorized to work in the United States; no visa sponsorship expected

Skills

• Quality Management Systems knowledge and regulatory requirements
• Regulatory inspection readiness and execution experience
• Experience supporting large manufacturing and warehouse operations
• Experience with automated manufacturing processes
• Experience with Manufacturing Execution Systems and electronic batch release
• Excellent interpersonal, written, and oral communication skills
• Technical aptitude with ability to train and mentor others
• Strong problem-solving and data analysis abilities

Education

• Bachelor's degree in a science, engineering, computer, pharmaceutical related field or equivalent experience

Additional Requirements

• Ability to work 8-hour days Monday through Friday; overtime as required
• Travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations