VP Operations

About the Role

The Vice President of Operations will report to the Chief Operations Officer, North America, and is accountable for the overall North America manufacturing operations with a primary focus on safety, reliability, manufacturing performance, and process engineering. This role includes site management, compliance with all regulations, production activities, process and asset reliability systems, manufacturing and process engineering, technical services management, facility management, and personnel management of all site employees. Partnering cross-functionally with other site functional leaders who report to off-site executives is paramount for success.

Responsibilities

• Ensure the site is compliant with all regulatory requirements, including Quality-related issues, Health, Safety & Environmental, Radiation Safety Programs, Hazardous Material Handling & Disposal, and Facilities code.
• Champion a strong safety culture and ensure internal audits are performed to continuously monitor compliance with all aspects of site operations against ever-changing regulations.
• Develop specific improvement plans and budgets to move the site from a state of compliance to a state of Regulatory Excellence.
• Develop and implement reliability systems for all process, manufacturing, and facility equipment, leveraging process engineering and continuous improvement disciplines.
• Identify issues and track resolution of the most critical reliability concerns to result in higher on-stream times, improved manufacturing throughput, and lower costs.
• Support and develop every role within the organization, fostering knowledge sharing and growth.
• Maintain operational compliance with US and international regulatory agencies and guidelines (e.g., FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
• Manage utility and facility support infrastructure reliability programs.
• Oversee site expense expenditures to drive financial performance and exceed established financial targets.
• Lead strategic maintenance and growth planning, including managing resulting capital projects.
• Demonstrate project management experience with effective cost controls, risk mitigation techniques, and scheduling accomplishments.
• Negotiate contract terms and conditions.
• Articulate examples of innovation that have improved business operations.

Requirements

• Bachelor of Science degree required; Master of Science degree preferred.
• 18+ years of relevant experience in managing operations, with 10+ years in a leadership role.
• 5+ years of manufacturing experience in the pharmaceutical industry.
• Demonstrated experience in process engineering, including process design, optimization, scale-up, validation, and troubleshooting in a regulated manufacturing environment.
• Proven track record implementing asset and process reliability programs (e.g., preventive/predictive maintenance, root cause analysis, RCM) to maximize on-stream time and equipment availability.
• Experience with managing radiopharmaceutical operations, cyclotron operations, or PET networks is desired.
• Experience driving compliance with local, state, national, and international regulatory bodies (e.g., FDA, DEA, HC, EU, TGA, NRC, OSHA, EPA) through continuous improvement plans.
• Demonstrated commitment to safety management to protect employees, contractors, visitors, and the community.
• Experience leading manufacturing operations and process engineering to deliver safe, reliable, and high-throughput production.
• Project management experience with effective cost controls, risk mitigation, and scheduling.
• Exceptional written and verbal communication skills, with the ability to compile concise and convincing documents and deliver presentations.
• Ability to read and interpret engineering documents (e.g., schematics, wiring diagrams, piping diagrams, blueprints) is a plus.
• Proficiency with computers and software, including CMMS and ERP systems.

Working Conditions

• Willingness to work in a plant producing radioactive materials, requiring participation in safety programs to minimize potential and/or actual exposure levels.
• Ability to lift up to 70 pounds, kneel, crouch, twist the upper body, walk, bend, stoop, push, pull, and reach.
• Must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Use of material handling devices (e.g., hand truck, fork truck, conveyors) when possible; proper lifting techniques are necessary to prevent injury.
• Willingness to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day.
• Must possess good hand-eye coordination and close attention to detail.
• Ability to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable, and toxic materials, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes and work in a team-based environment.
• Must be able to work outside of regular work hours, including off-shift, weekends, and holidays as business needs require.
• Willingness to travel up to 30% as required by business needs.

Schedule

Monday – Friday, 8:00 AM – 5:00 PM.