Operations Project Manager

About the job

The Aseptic Operations Manager leads all compounding and fill activities. Duties include oversight of business unit colleagues, direct accountability for setting the organizational direction, deploying resources, and leading performance, goal setting, and development activities. The role will work in partnership with the Pharmacist in Charge (PIC) to deliver a best in class production environment increasing safety, quality, manufacturing and financial performances.

• Ensuring safe work environments, enforcing operational discipline, and monitoring aseptic behaviors.
• Efficiently utilize tools and metrics (KPI’s) to monitor staff productivity, deliverables, timelines, and
quality of work product to adjust staffing levels and operational processes as needed to ensure
operational effectiveness.
• Support investigations, own CAPAs, and drive continuous improvements throughout operations.
• Responsible for developing staffs’ performance goals, maintaining positive employee morale and
relations and managing paid time off
• Understanding of the importance/impact of cGMP standards.
• Responsible for handling disciplinary actions and/or Performance Improvement Plans, terminations,
escalating complex employee issues to their manager or human resources and ensuring a fair and
consistent approach with all team members.
• Identifying potential process/product improvements and working collectively with cross-functional
teams to implement process/procedure updates.
• Demonstrates strong industry knowledge and comprehensive understanding of business processes.
• Demonstrates technical/functional expertise in applicable discipline and acquires knowledge in
related disciplines.
• Actively working within cross-functional teams in order to improve overall performance through
sharing knowledge in related disciplines while solving moderately complex problems.
• Utilize industry technical/functional experience to help develop standard operating procedures.

Set yourself apart

• Minimum of a Bachelor Degree in a scientific, engineering, or business discipline required. Advanced
degree/certification preferred. The position requires technical and business competency in all aspects
of this job description.
• 5-8 years manufacturing or engineering experience, preferably in sterile manufacturing and a good
understanding of quality and compliance requirements pertaining to cGMP and 21 CFR 210 & 211.
• 2-5 years management experience; with no fewer than 25 direct/indirect reports.
• Proven effective verbal and written communication skills
• Experience working with standard ERP/MRP systems.
• Experience interpreting compliance requirements and regulations is required.
• Knowledge of DEA, FDA and state regulations pertaining to manufacturing and handling of controlled
substances.

What’s on offer?

Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.
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