The Product Quality Surveillance Senior 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 Senior 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 not limited to Product Quality Complaints and support for the integration of new product acquisitions into post marketing product quality surveillance.
85% Post Marketing Product Quality Surveillance:
• Provide support to delivery, drive and maintain effective Product Quality Surveillance systems including but not limited to:
o Effective global Product Quality Compliant Handling
o 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 shall:
• Process global commercial / clinical product Quality Complaints received
o 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
o Assign actions related to each PQC investigation and work with the appropriate Technical and Quality personnel to drive timely delivery of these actions
o Perform trend analysis on all incoming PQCs and escalate potential risks to management
o Communicate adverse events reported in conjunction with PQCs to Shire PVRM
o Facilitate complaint sample returns (from consumer, pharmacy, healthcare provider or distributor)for inspection / investigation
o Coordinate pharmacy credits for returned product through Shire Customer service
o Coordinate process and review PQC investigations performed at contract site manufacturer / packagers and Shire site investigations in conjunction with Quality Assurance
o Evaluate PQC investigation results to ensure adherence to cGMP guidelines and expectations (including device and Combination product cGMPs) in conjunction with technical and quality SMEs as appropriate
o 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.
o Generate reports for management and inspections as required
o Assist as needed in the preparation of data for internal audits and external audits / inspections
o Participate in third party call monitoring to ensure correct communication strategies are being utilized.
o Assist as needed in preparation and evaluation of complaint summary and trend reports
10% Acquisition & Integration Support:
• Support and facilitate delivery of products entering the in-line supply chain into the Product Complaint Quality System.
5% Regulatory Awareness, Inspection support and Compliance
• 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.
• When appropriate, assist in regulatory inspections regarding Shire products and post marketing product surveillance activities.
• When appropriate, assist in regulatory notification or market correction activities (i.e. field alert / 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)
Education & Experience Requirements
• Minimum of a Bachelor's degree in a relevant scientific/engineering discipline with at least 5 years GMP industry experience, the majority of which has been gained in the QA environment and includes manufacturing related experience.
• The Senior Specialist will be strong scientifically with technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk based recommendations.
• Working knowledge of Regulations, US and EU Regulations, including cGMPs, and GDPs, including knowledge of Controlled substance standards accommodating for example, DEA, IMB, UK Home Office etc.
• Strong working knowledge of electronic data management systems (e.g. TrackWise and Master Control)
• Strong working knowledge of Microsoft Office applications (e.g. Word, Excel, Power Point)
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.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.