Associate Director - Parenteral Operations

Role Summary

The Associate Director - Parenteral Operations is responsible for overseeing the day-to-day activities of their operational area as well as planning for the 3-6 month horizon. They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational execution, sterility assurance, and continuous improvement. They are also responsible for leading the respective cross-functional process team(s) per Lilly’s Manufacturing Standards for Operational Excellence. As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles.

Responsibilities

• Leading by example with a Safety first, Quality Always mindset and encouraging Stop Work Authority for all employees if there is a perceived unsafe or product impacting situation.
• Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups.
• Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.
• Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
• Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve.
• Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
• Understand and influence the manufacturing control strategy for their area.
• Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.
• Responsible for a work force of approximately 40–70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them.
• Provide leadership and develop objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people.
• Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety.
• Leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support.
• Represent their Operations Process Team on the Plant Flow (value stream) Team.

Qualifications

• Required: At least 7 years working in the pharmaceutical industry.
• Required: Previous management or leadership experience including leading or working effectively with a cross functional group.
• Required: Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA.
• Required: Excellence in interpersonal, electronic, written, and oral communication.
• Required: Strong technical aptitude and ability to train and mentor others.

Education

• Bachelor's degree in a STEM or pharmaceutical related field of study.

Additional Requirements

• Ability to wear safety equipment (glasses, shoes, gloves, etc.).
• Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives.
• Position will involve frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and to build global network.
• Travel domestically and internationally, up to approximately 20% of the year to learn and network with colleagues.