Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
The Quality Manager 1,in the Quality Compliance group, is responsible for managing and/ or supporting Quality Systems which include the following:
• TrackWise 8
- Global Event Management System (GEMS),
- Inspection and Customer Audit Management System (ICAMS)
- Quality Regulatory Audit Management System (QRAMS)
- Change Control Management
• Laboratory Information Management System (LIMs)
• Veeva Document Management System
• OpenLab (Ipsen TrackWise records repository)
Also manage and support in the following:
• Quarterly Management Reviews
• Annual Product Quality Reviews
• Regulatory Inspections including response tracking
• Corporate Audits including response tracking
• Incident Escalation Council
• Biologic Product Deviation Reports (BPDRs)
• Field Corrective Actions (FCAs)
Manage the following Quality System groups for Change Control, TrackWise Administrator, LIMs, Document Management System, Complaints
Query and generate report to systems as requested
Manage User Requirements in TrackWise
Train user’s on TrackWise and other Quality Systems
Ensure upgrades are current or be the “Voice of the Customer” for improvements to the systems
Ensure compliance with all regulatory standards, systems, procedures and practices including cGMPs and other regulatory requirements as it related to Quality Assurance activities in the manufacturing facility
Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
May supervise others, to include coaching, training and development of subordinates
Participate in and provide PowerPoint slides for Quarterly Management Reviews
Coordinate activities related to Annual Product Quality Reviews (i.e.: gathering data from Subject Mater Experts, compiling data into approved template etc.)
SupportRegulatory Inspections including response tracking
Support Corporate Audits including response tracking
Support Incident Escalation Council, if needed
Support Biologic Product Deviation Reports (BPDRs), if needed
Support Field Corrective Actions (FCAs), if needed
Education and Experience Requirements
BS in science. 5+ years experience in Quality, Manufacturing, Engineering or related field which should include 1-2years of supervisory experience.
Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Strong analytical and problem solving skills.
• Ability to manage/supervise a team of employees.
• Good communication and leadership skills
• Good interpersonal/communication/influencing/negotiation skills.
Ability to drive projects to closure and the flexibility to adapt to changing priorities, while demonstrating proven leadership in planning and managing tasks. Compliance record workflow decision making and escalation determination a key role with the experience and judgment to defer to management when necessary.
Must be able to communicate with individuals from internal departments and describe processes and procedures to regulatory authorities. Ability to work effectively with contract manufacturers in order to sustain product delivery.
Req ID: R0020051