業務内容
・Reports To: Quality Director, CSS
・Department: Quality Unit - CSS
◎Quality Control leadership role in a fast-paced, customer focused organization.Performance driven culture rewards integrity to corporate values and delivery of results. Collaborative and inclusive work environment in a professional office
setting.
【SUMMARY OF ESSENTIAL FUNCTIONS】
The following summary represents an ideal situation for a site with a high degree of operational excellence and a mature Quality Culture. Regardless, the Site Quality Manager will implement strategies and tactical objectives to move the site towards this general model over time.
General allocation of time, effort, and attention:
• 20% Site leadership: As a member of the Site Leadership Team working with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational Excellence, continuous improvement,
error reduction, regulatory compliance, and sound fiscal responsibility.
Lead the development of site Quality Objectives, site Quality Plans,Quality Management Reviews, etc.
• 60% Department leadership:
- Overall responsibility for the site Quality Control and regulatory compliance functions including (but not limited to) those
responsibilities listed below.
- Oversee and execute all Performance Management Program (PMP) actions for the site Quality Control team. This includes
professional development counselling, informal and formal performance appraisals and feedback, and talent development/succession planning.
• 20% Personal Leadership: Professional development, managing work-life balance, strategic planning, etc.
【SPECIFIC SITE DUTIES, ACTIVITIES, AND RESPONSIBILITIES】
The following list is not comprehensive. Additional tasks and responsibilities may be assigned by Quality Director or arranged with the Site Leadership Team.
Accountable and responsible for the following programs (as applicable to the site):
• Internal Investigations on cGMP issues, trends, and customer complaints
• Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity
• Site Data Integrity programs
• Process integration and procedural harmonization with other CSS sites
• Raw materials and finished goods release processes
• Communication and escalation of quality issues to Site Leadership Team and Quality senior management
• Site Environmental Monitoring Program
• Site Label Control, including review, release and approval process
• In-process QC activities, including line clearance and room release, IN process and receiving inspections, and raw material/product sampling
• Implement Global quality policies and standards and CSS network procedures at the site
• Continuous process improvements, particularly as a function of site deviation rate and recurrent deviation rate
• Maintain robust relationships, interactions, and communications with client counterparts
• Site Recall/Quality alert program
• Facility/equipment/process/analysis method/cleaning validation and qualification program
• Site Risk Management
• Site Change Control/ change management programs
• Other duties as assigned by Quality Director