Shire Product Quality Surveillance Manager - Global in Dublin, Ireland

Primary Role

The Product Quality Surveillance Specialist – Commercial Complaints is an experienced Quality and Technical professional who delivers the Product Quality Surveillance activities for Shire’s pipe-line products and appropriate support for in-line products to enable a sustainable existence on the market.

  • Product Quality Surveillance Specialist works closely and collaboratively with the Product Quality Management Leads, Technical Operations and other Shire functions / stakeholders across the Business to execute product quality surveillance strategies specifically Product Quality Complaint administration. This includes, but is limited to Product Quality Complaints, Product Quality Review / Annual Product Review, Product Recall, Incident Management, and support for the integration of new product acquisitions into post marketing product quality surveillance.

  • Actively involved in daily operations and coordination to meet schedules and resolve issues. Escalates to management when challenges occur. Actively involved in resolution of complex problems.

Essential Functions

Responsibilities

Post Marketing Product Quality Surveillance:

  • Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:

  • Effective global Product Quality Compliant Handling

  • Effective global Product Annual / Periodic Product Quality Review

  • Effective global Product Recall Management

  • Support the provision of metrics regarding key performance indicators of quality from Product Quality Surveillance System in support of Shire and Shire’s Suppliers

Specifically the Complaint Specialist II shall:

  • Process global commercial / clinical product Quality Complaints received

  • Assess incoming Product Quality Complaints (PQC) elevating potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations

  • Critical evaluation of Customer Report complaints for serious cGMP and Device/ Combination product violations.

  • Assists with investigations on higher risk complaints, such as those that may or have led to Regulatory /Field actions. Lead investigation meetings as needed.

  • Performs Management review and final closure in TrackWise of Patient Inquires, Partner Notifications and Customer Report Complaints. Escalates potential Regulatory /Field actions to management.

  • Point of contact for International colleagues and LOC contacts and provides guidance to global partners.

  • Liaise with International Quality and global PQS Staff to ensure intake of appropriately redacted international complaint data is received, assessed and processed and escalates potential issues/ incidents to management, including but not limited to Field alerts, PDRs, BPDRs, MDRs or possible recall situations are escalated appropriately

  • Assign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions

  • Perform trend analysis on all incoming PQCs escalating to incidents and potential risks to management.

  • Primary Contact for Pharmacovigilance for reconciliation of AEs and Complaints. Assesses Complaints for reportability and categorization. Communicate adverse events reported in conjunction with PQCs to Shire PVRM.

  • Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor) for inspection investigation.

  • Coordinate pharmacy credits for returned product through Shire Customer service.

  • Coordinate process and review PQC investigations performed at contract site manufacturer packagers and Shire site investigations in conjunction with Quality Assurance.

  • Evaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combinat ion product cGDPs) in conjunction with technical and quality SMEs as appropriate.

  • Generate final correspondence summarizing investigational findings and communicate via letter or fax to complainant or communicate via the relevant international Shire QA to ensure local communication requirements are met.

  • Contact Trainings for lead of PQC team and external partners. Participate in third party call monitoring to ensure correct communication strategies are being utilized.

  • Subject Matter Expert and primary contact for TrackWise Complaint process. Identifies system changes and enhancements. Initiates and drives system changes to implementation.

  • Assigns and conducts training to new employees on PQC processes

• Perform Trend and Key Performance Indicator Analysis

  • Conducts in depth analysis of complaint trends. Evaluates trending data and selects methods for in depth analysis based on data and results.

  • Responsible for completing complaint trending for the Annual Product Review and authoring Complaint section summaries.

  • Develops and implements actions associated with product quality complaints and trends are appropriately assigned and implemented.

  • Compiles and communicates product quality complaint performance measures and Product Complaint Quality Management system measures and associated action plans to Management.

  • Review and Confirm Compliance Index reports for accuracy.

Acquisition & Integration Support:

  • Support and facilitate delivery of products entering the in-line supply chain into Quality Systems, including but not limited to; APQR, Product Compliant System, and Product Management and monitoring programs such as Critical Process Verification and monitoring.

  • Lead implementation of TrackWise Complaint workflow changes as TrackWise SME.

Regulatory Awareness, Inspection support and Compliance

  • Primary Contact for generation of reports for management and inspections as required.

  • Maintain awareness of MHRA/HPRA/EMA/FDA/DEA, etc. regulatory actions that may affect Shire’s products.

  • Supports regulatory reporting and submissions as applicable.

  • Keep informed of all regulatory changes, rulings and current industry practices concerning Post Marketing Surveillance activities.

  • Primary backup to management in support of regulatory inspections regarding Shire products and post marketing product surveillance activities.

  • Primary backup to management in support of regulatory notification or market correction activities (i.e. field alert and recall activities)

  • Initiate, author, revise or assist in the review of SOPs, and other Shire cGMP documentation including but not limited to CAPA, Deviation, etc)

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

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.