Sr. Manager - QA Incoming Batch Disposition

Lilly • NC

109d • $91,500 - $134,200

About The Position

The Quality Assurance Manager is responsible for support of the quality disposition of materials, semi-finished and finished goods for the RTP production site. The role will help build a strong quality culture and be responsible for oversight and support of the ongoing operation as well as site inspection readiness and execution. The Manager reports to the Associate Director-Materials QA.

Requirements

• Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study or equivalent experience
• Previous experience working in the pharmaceutical industry in QA/QC roles
• Previous management or leadership experience including leading or working effectively with a cross functional group
• Qualified candidates must be legally authorized to be employed in the United States.

Nice To Haves

• Strong knowledge of Quality Management Systems and applicable regulatory requirements
• Previous regulatory inspection readiness and inspection execution experience
• Previous experience directly supporting a large manufacturing and warehouse operation
• Previous experience with highly automated manufacturing processes
• Previous experience with Manufacturing Execution Systems and electronic batch release
• Excellent interpersonal, written and oral communication skills
• Strong technical aptitude and ability to train and mentor others
• Previous facility or area start up experience
• Previous experience with SAP or other inventory management systems
• Previous experience with deviation and change management systems including Trackwise
• Previous experience with Lean, Six Sigma or other known improvement methodology

Responsibilities

• Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures
• Build a diverse and capable organization to support quality oversight, and ensure compliance with area procedures and controls for material and product record review and release
• Drive operational excellence in disposition process through data analysis to reduce variability and shift performance cycle times to align with supply delivery targets
• Supervise, coach, and aid in development, performance management, ensure 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
• Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management
• Interact with the project and functional areas to coordinate activities to support the overall project and site schedule
• Setting of area human resource and business plan goals

Benefits

• Eligibility to participate in a company-sponsored 401(k)
• Pension
• Vacation benefits
• Eligibility for medical, dental, vision and prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
• Company bonus eligibility depending on company and individual performance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees