Regulatory Policy Specialist developing regulatory case filings and strategies supporting company goals at Xcel Energy. Collaborating with stakeholders and senior management to ensure compliance and effective communication.
WS
Hybrid Manager, Quality Systems and Compliance
Posted last week
About the role
- Manage quality systems and compliance activities for West Pharmaceutical Services. Overseeing audit management and continuous improvement of processes while ensuring compliance with quality standards in Ireland.
Responsibilities
- 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.
- Site QA Manager designee for QA Systems and customer engagement activities.
- Customer and Regulatory audit support Hosting Audits.
- Monitor trends in association with quality systems use and effectiveness (Deviation, CAPA, Change Control, Periodic Documentation Review etc.).
- Ensure GMP training of site personnel in relation to systems use and audit practices.
- Perform QA Sys Engineer tasks as required.
- Identify and develop opportunities to improve existing processes and procedures in line with corporate and customer requirements.
Requirements
- Bachelor's Degree in Quality/ Engineering/Science or business systems.
- 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.
- Lean/Six Sigma principles.
- Audit Management.
- Quality Risk based thinking and decision making.
- 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.
Benefits
- Performance-based bonuses
- Service recognition
- Employee appreciation initiatives
- Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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