Other Locations:US- NJ- Summit West
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.
Sr Manager, Global Supply Chain Process & Technology (Serialization)
Global Supply Chain Operations
Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields; advanced degree (MBA) preferred.
10 - 15 years of experience in supply chain (packaging & distribution/logistics preferred) and/or related systems management preferably within a pharmaceutical operations environment.
3 - 5 years of supervisory experience preferred
3 - 5 years of experience in the design, development, testing, deployment and day-to-day management of serialization (TraceLink) and supply chain ERP systems (Oracle) and related boundary applications preferred.
This position plays a key management role bearing responsibility for defining, leading and executing the strategic direction and oversight of information systems supporting all commercial product serialization related functions within Global Supply. Incumbent will be committed to achieving excellence in process & technology management as measured (in part) by a) their effectiveness in supporting Global Supply business functions as well as related processes in other functions (i.e. Finance, I.T., etc.); b) integration between systems such as Enterprise Resource Planning (ERP) and serialization management; and c) the delivery of accurate data in meaningful reports for decision making. The incumbent must excel at working in a collaborative, diverse, complex, resource-constrained environment and be able to lead decision-making processes that involve multiple constituencies and constraints. He or she will be expected to continuously improve processes and technologies that fall within the range of their responsibilities.
Responsibilities will include, but are not limited to, the following:
- Develop and implement a global vision for the Process & Technology group supporting commercial product serialization business processes with appropriate strategies that support both the short and long term operational objectives of Global Supply.
- Work with global manufacturing and logistics groups to establish an efficient commercial product serialization operational model and a multi-year roadmap of strategic initiatives to build capabilities that support global, regional and site level objectives.
- Collaborate with executive management and key stakeholders in Global Supply and other functions to develop & execute strategies for improving commercial product serialization related business processes and systems.
- Act as the key liaison between Global Supply & IT/Finance for all commercial product serialization applications within Global Supply.
- Collaborate with I.T. Business Partners to ensure that system support models effectively meet commercial product serialization operational requirements. Define service level management scope and processes with I.T. and/or 3rd parties including Service Level Agreements (SLA’s), Disaster Recovery/Service Continuity, etc.
- Implement and lead governance management for all commercial product serialization related systems within Global Supply. Act as Global Supply representative to cross-functional governance committees (i.e. PAB, CAB, etc.)
- Maintain a detailed and expert knowledge of current and future serialization related regulatory requirements
- Direct the day-to-day management of Global Supply commercial product serialization information systems portfolio.
- Participate on the commercial product serialization core team to insure serialization system solution and processes meets regulatory timelines and deliverables.
- Work closely with operational groups to successfully manage and implement commercial product serialization system pilots (Germany, U.S., etc.).
- Work cross-functionally to prepare policies, standards, SOP’s and work practices including validation change controls, application testing, documentation management, incident and problem management, etc. required for global regulatory compliance (serialization, GxP) and effective commercial product serialization process / technology management.
- Manage commercial product serialization related application expansion & upgrade planning activities including business user requirements, project costs, schedules & resources, capital appropriation requests (CAR), cost-benefit analyses, user licenses, etc.
- Ensures documentation of business processes such as swim lane diagrams, work flows, etc. and related applications such as business requirements (BR030), system configurations (BR100) and enhancements (MD050, MD070, etc.) are maintained and updated as needed to maintain the GMP/GDP validated state of applications.
- Evaluate and identify solutions to business process & related system issues. Evaluate & test supplier provided patches and work with technical teams in I.T. to develop fixes as needed.
- Evaluate and facilitate prioritization of user requests for enhancements and/or upgrades of commercial product serialization related business applications. Maintain active communication with business users and stakeholders to manage expectations regarding application changes and the introduction of new and enhanced functionality.
- Act as a source of knowledge in areas of supply chain best practices and methodologies. Integrate supply chain best practices within business processes to enhance supply chain efficiency.
- Act as functional project manager for changes to commercial product serialization applications and business processes. Coordinate project team members, consultants and subject matter experts in design, configuration, testing, training, deployment and post go-live support activities. Track and monitor team progress and take steps to proactively remediate issues that adversely impact business operations, project scope, budgets, schedules, resources and deliverables.
- Facilitate appropriate communication and training related to all project activities.
- Work with leaders in Global Supply, Finance, Commercial Operations, Information Technology, etc. on cross-functional systems initiatives.
- Define and direct ongoing knowledge management processes for commercial product serialization systems within Global Supply
- Direct the development of reports to support decision-making by senior management within Global Supply including key performance indicators (KPI’s), variance to plans, etc.
- Remain current on new industry-based trends as well as supply chain best practices and related software applications.
- Span of Control – Global commercial product serialization within Global Supply
- Direct Reports – 1 or more direct reports (future)
- Indirect Reports – 10 to 20 project and site resources (internal and external)
- Budgetary Responsibility – Approved project budgets
- Interacts with – line management across Global Supply, Regulatory, Finance and I.T.
- Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields; advanced degree (MBA) preferred.
- 10 - 15 years of experience in supply chain and/or related business systems management preferably within a pharmaceutical operations environment. Application management experience specifically within commercial product serialization (i.e. TraceLink), ERP (i.e. Oracle OPM & OM), electronic data interchange (EDI), GxP document management (i.e. Documentum), GxP learning management (i.e. Kaplan, Plateau), etc. is highly desired.
- 3 - 5 years of supervisory experience (pharmaceutical supply chain process and technology support preferred).
- 3 - 5 years of experience in the design, development, testing, deployment and/or day-to-day management of commercial product serialization (TraceLink) and/or supply chain ERP systems (Oracle or SAP) and related applications.
- Prior experience in various supply chain operations including but not limited to inventory management, packaging, warehousing, order management, distribution/logistics, etc.
- People & project management experience, preferably in a matrixed, multicultural global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills
- Working knowledge of international pharmaceutical GMP/GDP regulatory requirements and the role applications play in satisfying those requirements. Ability to facilitate translation of business requirements and application capabilities.
- Knowledge within all areas associated with commercial product serialization including EPCIS, GS1 serialization and track and trace standards
- Thorough understanding of best practices in Supply Chain operations, project management, master data management, GxP change controls and Solution Delivery Life Cycle (SDLC).
- Strong project management skills including the use of tools such as Gantt charts, critical path analysis, risk mitigation strategies and project management software (i.e. Microsoft Project).
- Prior experience leading project teams for implementation, customization, or enhancements to commercial off the shelf systems and custom developed applications strongly preferred.
- Strong background in process and controls and understanding of the operating business environment from a controls and compliance perspective
- Ability to work independently with internal and external groups on multiple simultaneous projects
- Excellent customer service skills, with strong relationship management and analytical skills
- Strong skills in communications, change management, staff mentoring, performance evaluation, life-long learning and diagnosis of problems in business processes and systems.
- Familiarity with business intelligence and reporting tools (i.e. Oracle OBIEE, Business Objects, or similar tools.)
- Understanding of financial concepts such as Total Cost of Ownership (TCO), Return on Investment (ROI), Net Present Value (NPV), etc. including the development of business case documentation.
- Experience with developing annual capital and operating expense budgets.
- Flexible, adaptable and hands-on approach is necessary.
- Six Sigma and Lean Manufacturing experience a plus
- Proficient with Word, Excel, PowerPoint, Visio and Project Management tools.
- Willing to travel 10 - 20% domestically and internationally often on short notice.
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.