Title:  Manager, Quality Systems and Compliance

Job Summary

Manage the day-to-day planning and supervision of quality systems activities including quality systems availability, audit management, customer feedback and enterprise management system quality master data.  Ensure continuous improvement of processes to ensure quality product and customer service.  Representative for Global systems projects and systems upgrades

Essential Duties and Responsibilities

• Site QA Manager designee for QA Systems and customer engagement activities.
• Customer and Regulatory audit support
• Hosting Audits
• Prioritize & manage available QA systems resources to ensure on time scheduling and response timelines are achieved for customer audits, notifications responses, management reviews, and customer complaints
• Ensure Waterford are represented in Global Quality System Project deployment to ensure compliance to standards and efficiency in doing business.
• Prioritize & manage available QA systems resources to ensure schedule adherence for quality reporting.
• Prioritize & manage available QA operations resources to ensure schedule adherence for master data creation for technical transfer & new product introduction activities.
• Monitoring of trends in association of quality systems use and effectivity (Deviation, CAPA, Change Control, Periodic Documentation Review etc.)
• Ensure GMP training of site personnel in relation to systems use and audit practises.
• Perform QA Sys Engineer tasks as required.
• Identify and develop opportunities to improve existing processes and procedures in line with corporate and customer requirements.
• Ensures compliance with Customer Agreements and Specifications, Applicable ISO standards and regulations.
• Endorses an “Audit Ready Every day” and Customer Focussed Culture
• Perform routine visual inspection of work areas for unusual occurrences, safety hazards, housekeeping, work space organization and control.
• Monthly and quarterly reporting of Quality Key Performance Indicators (KPI’s)
• Interface with other West sites with respect to sharing of best practices.
• Lead in the continuous improvement of Xs processes- playing an active and key role supporting the team in continuous improvement initiatives/projects.
• Responsible for the execution of training for the team; identification of training requirements for the team.
• Own the development process for each team member. Delegation of development objectives and activities Assigning tasks, reviewing work and completion of appraisals in line with the company targets.
• Manage the team’s performance, conduct performance 1 to 1’s, support recruitment, training and development plans while addressing any issues that arise in a timely manner.
• Maintain a positive employee relations atmosphere. Ensure that there is good communication and co-operation by encouraging knowledge sharing.

Additional Responsibilities

• Ensure adherence to corporate Quality System requirements

Education

• Bachelor's Degree in  Quality/ Engineering/Science or business systems. 

Work Experience

• Minimum 5 years’ experience preferably in a high volume GMP environment in a Quality Assurance/Quality System function.
• Must have a thorough understanding of ISO 9001 and/or ISO 15378, ISO 13485, cGMP quality management processes
• Customer feedback and audit management experience
• Must have thorough understanding of enterprise and document management system requirements.
• Prior Supervisory experience is an advantage

Preferred Knowledge, Skills and Abilities

• Lean/Six Sigma principles
• Leading & Managing Others
• Audit Management
• Quality Risk based thinking and decision making.
• Natural ability to work in team oriented environment
• Must have excellent communication skills both oral and written.
• Must be able to prioritize and organize tasks using shared systems.
• Regulatory training is an advantage.
• Problem solving including root cause failure analysis methods
• Proficient in statistical software, Windows OS, Microsoft Office Suite including Word, Excel, and Power Point
• Able to comply with the company’s safety policy at all times
• Knowledge of cGMP, cGDP

Travel Requirements

Physical Requirements

What We Offer