Quality Systems Manager

at  CSL Plasma

THE OPPORTUNITY

Reporting to the Associate Director of Quality Systems - Manage staff, including selecting, training, developing, coaching and terminating, as applicable with guidance from Human Resources. Ensure accurate reporting of all consignee notifications (Lookback/Lookforward), Biologic Product Deviation Reports (BPDRs), and recalls consistent with customer and regulatory requirements.

YOUR QUALIFICATIONS

• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, or Biochemistry)
• 3+ years’ GMP experience in pharmaceutical/biotech or other regulated industry• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of FDA and EMA requirements

1. Provide guidance to department personnel in resolving discrepant/missing information required for these reports and ensure follow-up with regulating agencies.
2. Manage compliance to and successful use of the Quality System tools such as change and deviation management. Ensure regular management review of quality performance that delivers stable, high levels of compliance performance in assigned QA areas. Provide leadership and coordination to established automated systems for control. Provide QA oversight/approvals to New Center change control process.
3. Manage Key Performance Indicators (KPIs) performance to ensure meeting regulatory and departmental requirements, and to improve department processes. Work with CSL applicable systems to analyze and identify quality issues/trends and report those to appropriate Sr. Management.
4. Provide regulatory and SOP requirements for completion of lookbacks, and BPDRs guidance to plasma centers. Manage quality applications workflows, including DTAC, Plateau, Change Control and Deviation Management. Manage new systems, workflow changes, quality projects, and change control efforts.
5. Manage improvement opportunities for quality systems to ensure there are tools in place to support processes for deviation management, root cause analysis, preventive action, and effectiveness monitoring. Manage the change control systems to ensure compliance and communication measures are completed before deployment of change.
6. Assess and design departmental Standard Operating Procedures (SOPs) for all processes to ensure compliance with regulatory and customer requirements.
7. Mentor others on data analysis, technical problem prevention and resolution, design control procedures, investigation processes, and methods as it relates to quality systems.
8. Collaborate with the Global IT Quality Team and Quality Management Delegate(s) to ensure coordination of activities between the IT QMS and site quality system.
9. Manage an annual budget designed to exceed objectives by review of performance against goals.
10. Perform other duties, as assigned, to support our needs.