Associate Director - Parenteral Operations Expansion

Role Summary

Associate Director - Parenteral Operations Expansion oversees staffing, training, and leadership of the operations group supporting asset delivery, process development, operational readiness, start up, and validation of the Kenosha parenteral expansion. After startup, leads day-to-day activities of the operational area and plans for the 3–6 month horizon, guiding safety, quality, operational execution, sterility assurance, and continuous improvement.

Responsibilities

• Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.
• Manage a workforce of approximately 25‚Äì50 individuals on various shifts, with multiple shift supervisors reporting directly.
• Ensure consistency of operations across shifts through on-the-floor engagement and Gemba walks, plus Practice vs. Procedure evaluations.
• Provide leadership and develop objectives to deliver Business Plan Goals related to production volumes, financials, safety, quality, stewardship, and people.
• Maintain metrics to measure performance against objectives and implement changes to improve performance.
• Participate in strategies for Continuous Improvement, Root Cause Analysis, FMEA, and OSSCE.
• Lead area deviation and corrective action discussions with cross-functional teams (Engineering, Maintenance, TS/MS, Quality, HSE).
• Act as primary contact for Production Planning, HR, Quality Assurance, Engineering, and Environmental/Safety issues.
• Present operations investigations and procedures to Regulatory Agencies; act as SME for audit tours and discussions.
• Lead the Operations Process Team, a cross-functional group focused on making medicine, continuous improvement, and site support.
• Understand and influence the manufacturing control strategy for the area.
• Represent the Process Team on the Parenteral Flow Team.

Qualifications

• Bachelor's degree in a science, engineering, or pharmaceutical-related field.
• 5+ years of experience in the pharmaceutical manufacturing industry.
• 2+ years of management or leadership experience including cross-functional collaboration.
• Solid understanding of regulatory requirements from agencies such as FDA, EMEA, DEKRA, and OSHA.

Preferred

• Excellent interpersonal, written, and oral communication skills
• Strong technical aptitude with ability to train and mentor others
• Experience in operations, automated/semi-automated inspection, and manual inspection
• Experience with highly automated equipment and with creating SOPs and Work Instructions
• Experience with equipment design documentation reviews
• Facility or area startup experience
• Equipment qualification and process validation experience
• Experience with Manufacturing Execution Systems and electronic batch release
• Experience with ASRS/AGVs
• Experience in statistical process control and Six Sigma concepts
• Experience with documentation, deviation, and change management systems (e.g., Trackwise, Veeva QualityDocs)