Manufacturing Manager - Senior
Berkley Group
- Dublin
- Contract
- Full-time
The successful candidate will be responsible for managing and executing total quality management systems for the External Supply organization (Raw Materials Categories, Devices, and Contract Manufacturing).The Job:
- Position is expected to execute nonconformance, CAPA, SICAR, Change Control and metrics oversight responsibilities.
- Act as the category owner for all quality records and procedures.
- The Specialist processes, investigates and acts as first responders to deviations.
- Addresses and expedites product deviation under the company's quality management system procedures and ensures compliance with regulatory agencies.
- Monitors, investigates deviations, and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses.
- Maintains unified product defect investigation operating procedures.
- Provides technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent reoccurring events.
- Maintains and monitors systems to ensure that all deviations received are appropriately investigated and concluded per the company's quality standards and procedures.
- Master's degree and 5+ years of Quality and/or Manufacturing experience OR Bachelor's degree and 8 years of Quality and/or Manufacturing experience OR Associate's degree and 10 years of Quality and/or Manufacturing experience OR High school diploma / GED and 12 years Quality and/or Manufacturing experience.
- 6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
- Understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
- Thorough working knowledge of EU and US cGMPs regulations
- Demonstrated ability to work with minimal supervision, present data in an organized and logical manner, and communicate effectively.
- Demonstrated ability to coordinate and lead cross-functional project teams and deliver on schedule.
- Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
- Able to defend processes, procedures, and decisions during regulatory inspections.