Celgene Director, Quality IT Systems Delivery in Summit, New Jersey
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.
This member of the IT GDS Enterprise Systems leadership team will have accountability for the delivery of Quality IT Systems supporting manufacturing and development areas. The individual will lead the Quality IT Systems Delivery team comprised of several service group leaders with direct oversight for the enterprise quality management platform, GMP-regulated content management systems, and laboratory/supporting systems (LIMS, ELN, CDMS, Clinical Drug Supply, EHS). The successful candidate must be knowledgeable of current best practices and emerging trends in GMP compliance, as well as, IT support of laboratory systems and LIMS. They should be a seasoned leader with significant global experience in a GMP-regulated industry. This is an enterprise role with oversight for several services along with site laboratory IT operations in multiple locations ensuring compliance to regulatory and security requirements. Oversight of IT compliance-related Data Integrity/Data Governance programs is required. Customer groups span global GMP manufacturing sites, late-stage development teams, Regulatory Affairs, Biologics Development, EHS, Corp Quality and Compliance.
Celgene is seeking a results oriented leader in Quality IT Systems Delivery with in-depth knowledge of IT Managed Services, Service Management, Manufacturing, and Quality. This is a leadership position with a high degree of influence - success criteria for the role will be measured by customer and user satisfaction (enterprise and site level) as well as by the continuous availability and improvement of appropriate service levels for all service offerings across the enterprise.
Responsibilities will include, but are not limited to, the following:
The incumbent will be the leader in providing oversight to our Quality IT Systems Delivery group:
Acts as the Service Area Owner for global Quality IT Systems services at Celgene.
Provides oversight to application services from demand shaping of new capability requests through service transition and eventual service retirement (full lifecycle management).
Accountable for setting performance standards and directing IT GDS Quality laboratory operations teams.
Accountable for building and maintaining a leadership team capable of managing improvements to the full scope of IT application services delivered by the Quality IT Systems Team.
Continually measures the performance of service delivery and reports on efficiency, effectiveness, quality, and cost effectiveness of these service offerings.
Working in conjunction with IT GDS Operations and IT Business Partners, ensures that service levels are meeting the needs of our business colleagues and that user experience meets or exceeds expectations of consumers of our services.
Stays abreast of industry trends and brings innovative ideas for solutioning business capabilities.
Effectively manages a diverse global workforce comprised of both employee staff and managed services in a high growth area.
Collaborates across IT to manage Data Integrity/Data Governance programs related to Quality Laboratory Systems and ensures information management best practices are practiced.
Responsible for software license compliance, strategic IT roadmaps, governance, service level management, and new project delivery.
Span of Control – Enterprise, cross functional, in collaboration with IT GDS leadership, IT Business Partnership, IT PMO, IT Global Planning & Strategy, and with business colleagues in: Global Pharmaceutical Development and Operations (GPDO), Quality, and Strategic Sourcing.
Direct Reports – 5 to 6
Indirect Reports – will provide leadership oversight to a total team of over 10 employee staff across multiple sites along with managed services.
Budgetary Responsibility – Oversight of an operating budget of approximately $10 MM and over $5 MM in annual capital project work
Interacts w/ - ITSLT, IT Global Delivery Services (GDS) leadership, IT business partners, IT PMO, IT Global Planning & Strategy, External Strategic Partners, and Celgene business leaders and staff members in manufacturing and Quality.
Proficiency with recognized industry standards covering IT-enabled service management, IT Governance, and GMP compliance (ITIL, GAMP, cGMP).
Experience leading operations reliant on an outsourced service provider model.
Demonstrated ability to manage Quality laboratory IT systems operations is required.
Excellent interpersonal and communication skills. Must have ability to: a) effectively interact with executive and senior management to assess technology requirements and communicate service strategies and change initiatives; b) effectively lead matrix projects with global implications; c) set direction for large complex teams; d) work effectively as a team leader and team member.
Familiarity with ServiceNow and ITSM reporting and analytics within the ServiceNow platform a plus.
Previous QMS and LIMS delivery and support experience in a GMP-regulated industry with 10+ years leadership experience is required.
High preference will be given to experience in Pharma/Biotech.
Experience with Oracle EBS, Microsoft Dynamix, Documentum, Veeva Vault, and LabWare LIMS is desired.
BS in Engineering, Computer Science or related study required, MBA is a plus
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
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.