Celgene Senior Manager Risk Management Quality Operations in Stockley Park, United Kingdom
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Reporting to the Senior Director, Head of Drug Safety and Risk Management UK & Ireland this role leads all Quality Operation activities within the Celgene UK & Ireland Risk Management Operations team associated with the eRMP System and associated business processes, including the Quality Management System, and Quality Processes.
This role is responsible for generation and oversight of Key Performance Indicators associated with the operations of Celgene UK & Ireland eRMP System and for ensuring the department is positioned to pass all internal and external audits, and leading cross-functional strategy to achieve maximum compliance and adherence of health care professionals and pharmacies with respect to their obligations linked to Risk Minimisation activities established in Celgene UK & Ireland.
Roles and Responsibilities include, but are not limited to the following:
eRMP Quality Initiatives
Direct and manage Risk Management Operations quality activities within the RM operations and DSRM Team of Celgene UK & Ireland
Ensure all eRMP operatives have a comprehensive knowledge of eRMP Operations including all SOPs, work practices and systems and user guides
Define and Implement the eRMP Quality Systems in collaboration with Celgene UK & Ireland and GDSRM Stakeholders
Design and implement systems to efficiency support operations
Lead the quality assurance activities including necessary analysis of data processed within the RM Operations team to ensure accurate and timely handling and processing of PAF within the eRMP system to support generation of audit reports required for submission to the MHRA
Coordinate process of QC of Paper PAFs transferred into eRMP
QC Follow-up of illegible Paper PAFs ie, received via fax or illegible/missing information like pharmacist signature with external customers
Maintain reports and metrics regarding quality activities identifying, outcomes and trends and drive appropriate activities and change management as required
Celgene UK & Ireland eRMP Quality Management System
Maintain a thorough understanding of UK Risk Management regulations, and industry trends regarding the implementation of Risk Management Systems
Ensure Celgene is fully compliant with all aspects of the MHRA agreed PPP through effective operationalization of the eRMP System
Design, implement and maintain the Quality Management System in collaboration with GDSRM and IT Business Partners to support Celgene UK & Ireland eRMP Operations objectives
Manage the failure investigation and non-adherence processes in collaboration with Celgene UK & Ireland DSRM team, and corresponding CAPA system, to eliminate root causes of non-conformance
Develop & maintenance of Data Entry Conventions, SOPs/WPs and controlled procedures
Support and oversee IT technology enhancements in collaboration with Risk Management Operations and Global Drug Safety and Risk Management
Lead Data Entry personnel training
QC Data Extracted & Raw Data Handling Document for Regulatory Audit Reports
Reconciliation of Data Extraction of eRMP external Customers with trained pharmacist list
Oversee KPI management in coordination with the Risk Management Operations Team
Support Pharmacy Registration & Query Resolution
Support Sales/pack volume requests for the purposes of risk management related reconciliation
Follow-up as stated in Regulatory reports with non-adherent external customers
Enforce quality standards across all UK/IE department activities associated with Risk Management Operations, and work cross-functionally to resolve quality issues
Maintain reports regarding activities, outcomes, and trends
Lead preparation for internal process audit program in collaboration with GDSRM and Global Compliance to monitor compliance with internal and external standards
Ensure the UK RM Operations and UK/IE DSRM department would pass all internal audits and external inspections, partner with Global Compliance on training and awareness activities
Responsible for back-office activities for UK MHRA or HPRA inspections, and participates in responses as required
Responsible for leading CAPA associated with observations linked to Celgene UK & Ireland RM Operations team should they be raised working as applicable with affiliate and global counterparts.
Lead creation and population of Inspection and Audit support i.e. Readiness checklist for eRMP system
Support in collaboration with GDSRM Safety Operations vendor oversight activities as applicable to ensure the most efficient and value-added processing of PAF data within the eRMP system
Contribution to vendor selection in collaboration with GDSRM Safety Operations and EEA QPPV
Provide regularly trained Pharmacist list to LSP (Arvato)
Oversee LSP activities with regard to trained Pharmacist list handling
Support Training to vendors as applicable on quality management related topics
Support establishment of SLAs and quality metrics for vendor oversight
Department oversight and other tasks
Provides leadership, coaching, professional development, mentoring and support for direct reports, including talent planning and performance management. Exemplifies and promotes Celgene values and behaviors
Responsible for the financial planning and execution against agreed budget
Develop and maintain formal working procedures
Deliver presentations to internal and external audiences regarding UK/Ireland Risk Management Quality Operations
Provide scheduled and ad-hoc reports including updates on Key Performance Indicators to the Celgene UK & Ireland and GDSRM leadership teams as required Other responsibilities as assigned
- Responsible for line management of RM Quality Operations specialists
Decision Making Authority
- Responsible for decisions pertaining to ongoing quality process improvement, implementation of corrective and prevention actions as a result of internal process review, audit and inspection, updates to controlled procedures, recruitment and team development.
Key Performance Indicators
eRMP System Reporting
Quality Trending Reports
Corrective and Preventative Actions as required
Skills and Knowledge Requirements
BSc in Sciences or equivalent required/ Life Sciences Background
Solid pharmaceutical experience preferably within pharmacovigilance, with experience of risk management.
Line Management Experience.
Good knowledge of pharmacovigilance legislation.
Operations and customer service experience desirable, but not essential.
Strong process mindset and process development/documentation skills.
Good understanding of database systems and related IT terminology.
Good knowledge of medical terminology.
Excellent attention to detail.
Good Time Management.
Excellent communication skills, with a strong fluency in written and spoken English.
Adaptable and able to deal within a pressurized environment.
Enthusiastic, self-motivated and able to take the initiative.
Excellent computer skills; good knowledge of Word and Outlook is essential; experience with working with Excel.
Good presentation skills; comfortable presenting 1:1 and to groups.
Ability to manage external suppliers.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE