Director of Operations, Selution (Irvine, California)

$169,700 - $242,550/Yr

Cordis - Irvine, CA

Full-time - Senior

Irvine, CA

Miscellaneous Manufacturing

About the position

The Director of Operations for Selution at Cordis is responsible for driving strategy and implementation for all manufacturing projects related to drug-eluting balloons. This role involves managing and inspiring teams to resolve complex production challenges through innovative solutions, ensuring compliance with quality regulations, and fostering cross-functional collaboration to achieve operational excellence.

Responsibilities

• Directs plant operations through development and implementation of world-class policies and procedures.
• Ensures all Operations departments understand accountabilities through the establishment of department goals based on the business plan.
• Defines, initiates, and executes projects to improve short-term and long-term operations as appropriate.
• Tracks efficiency of Operations processes and adjusts schedules, resources, or procedures as needed to achieve business goals.
• Maintains strong relationships with R&D, Quality, Regulatory, Human Resources, Finance, Marketing, and Clinical departments to ensure cross-functional alignment on Operations initiatives.
• Fully understands the precepts of the Quality System Regulations (QSR) and ensures compliance with combination product regulations.
• Oversees implementation of corrective actions for inadequacies in process execution.
• Develops and ensures compliance to guidelines related to health, safety, and environmental practices.
• Prepares and manages plant's operational budget and implements effective cost control practices.
• Coaches, mentors, and provides developmental opportunities to staff.

Requirements

• Bachelor's degree in engineering or applied science; Master's degree preferred.
• 10 to 15 years of experience in Operations, Manufacturing, or related activities, preferably in medical devices or pharmaceuticals, with at least 5 years in management.
• Experience with operations scale-up, new product launches, combination products, quality systems, and good manufacturing practices.
• Strong verbal and written communication skills; comfort speaking in front of large groups.
• Ability to analyze and solve problems, and perform financial analysis.

Nice-to-haves

• Experience in the pharmaceutical industry.
• Knowledge of drug regulations and safety/environmental practices.

Benefits

• Competitive salary range of $169,700 - $242,550 per year.
• Opportunities for professional development and career growth.
• Supportive team environment with a focus on diversity and inclusion.