Associate Director - Device, Assembly, and Packaging

Responsibilities

• Staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) OR device, assembly, and packaging (DAP) areas.
• Ensuring the operations group meets annual production goals once the facility is turned over to operations.
• Leading cross-functional process teams.
• Direct line supervision for Supervisors and Operations Associates.
• Exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
• Presenting operations investigations and procedures to Regulatory Agencies and acting as a Subject Matter Expert (SME) for related inspections, tours, and discussions.
• Maintaining and communicating metrics to measure performance against business objectives and making necessary changes to continuously improve.
• Participating in the development and implementation of strategies focused on Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
• Understanding and influencing the manufacturing control strategy for their area.
• Supporting Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral/DAP manufacturing area.
• Leading the Operations Process Team, a cross-functional group charged with making medicine, continuous improvement, and site support.
• Representing their Operations Process Team on the Plant Flow (value stream) Team.

Qualifications

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