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Celgene Corporation

Sr Manager QA Logistics Americas

Celgene Corporation - Summit, NJ

Description 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, \u200bquest 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. PURPOSE AND SCOPE OF POSITION: The Sr. Manager, Quality Operations Logistics - Americas will be accountable and responsible for the development and implementation of regional distribution and logistics quality systems and processes. The position holder is responsible for ensuring that GxP regulated systems and processes are in place and in full compliance with regulatory requirements, company policies and procedures and provides quality leadership, direction and oversight to teams in Logistics and Supply Chain. This position will support the operations of the Celgene or Celgene contracted logistics\/distribution facilities within the Americas region and will manage logistics issues\/deviations, participate in regulatory inspections and internal audits and provide quality guidance on GxP regulatory requirements. This position will oversee and manage the quality aspects of warehousing, distribution, import\/export and freight forwarding activities at company warehouse and\/or third party locations internationally and shall ensure effective, efficient and compliant practices are in place. The incumbent will be responsible for implementation of strategic initiatives at assigned warehouse locations to best meet Celgene\u2019s requirements for quality, compliance, technology, delivery and cost. This position is integrated in the Global QA Logistics function and he\/she will work closely across both distribution and corporate functions to integrate the corporation\u2019s policy, process and technology for best results. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities Hands on knowledge and technical understanding of supply chain operations, sales & operations planning, materials management, logistics, warehouse \/ physical distribution, and customer order fulfillment. Understanding of logistics and customer service related key performance indicators (KPI\u2019s) and operational metrics. Working knowledge of international GMP\/GDP (Good Manufacturing and Distribution Practices) requirements and quality systems. Knowledge and experience in cost of goods management and corresponding financial impact of business decisions. Global operations experience, import \/ export operations, working knowledge of regulatory, compliance and operating requirements in a global market. Demonstrated ability to manage a complex project using tools such as Gantt charts, critical path analysis, risk mitigation strategies and project management software. Must possess highly developed project management, communication and analytical problem solving skills. Excellent written and oral communication skills in a global environment. Enterprise Resource Planning (ERP, Oracle) system experience and understanding of purchasing, planning, scheduling, inventory management and manufacturing information and related transactions. Demonstrated experience in establishing and maintaining supplier\/contractor relationships. Ability to raise levels of performance by establishing an improvement process, or setting specific, measurable targets and goals linked to business needs. Demonstrated leadership skills and ability to develop effective working relationships with internal\/external partners and cross-functional project teams. Proven ability to make independent and objective decisions and to work with minimal direct supervision. Strong team player with high level of integrity, energy and enthusiasm. Willing to travel up to 20% of time domestically and internationally often on short notice. DUTIES AND RESPONSIBILITIES Serve as the primary Quality Operations relationship manager with multiple international contract logistics and distribution facilities, mainly located in Americas. Provides primary point of contact for day-to-day decision making and elevation\/resolution of issues from both Celgene and external organizations. Direct the quality activities of multiple international contract distribution facilities in order to store, transport, import\/export and deliver the required products\/materials to internal and external customers in compliance with GDP standards and business needs. Secures necessary verification of transport conditions (qualification of routes), and implementation of monitoring or mitigation strategies as required. Lead or participate in qualification \/ validation activities for the transport and risk mitigation solutions. Provide GDP Support to the Celgene Affiliates located in Americas (e.g. Canada, Brazil and Mexico) to ensure compliance with Celgene and applicable standards. Provide support \/ lead development of GDP standards to govern the logistics processes globally and support regional implementation with the different stakeholders. Perform GDP trainings to the Celgene partners (Logistics operations and if needed other functions \/ affiliates). Integrate and coordinate activities across a matrix organization to ensure distribution, logistics and order management issues and questions are resolved quickly and root cause corrective actions are implemented and standardized. Accountable for all aspects of quality and compliance related performance for assigned warehouses and logistics operations. Ensure global policies, procedures and standards are implemented at assigned distribution and order processing facilities and participate in site audits designed to verify compliance. Perform\/support annual vendor assessments. Lead the implementation of controls required for storage, distribution and processing of commercial products at assigned logistics facilities and oversees control of Celgene products at regional distribution centers, including: holds and removal of holds, destructions and returns. Document, oversees and assess logistics issues\/deviations investigations at distribution centers involving discrepancies in material control systems related to quantity, identity, status, expiration date, theft or concealment; inbound standards, count discrepancies, etc. and assures appropriate CAPA are implemented. Oversees and approves the change managements and GDP related processes for assigned facilities. Represents Global Quality Operations regarding harmonized quality improvements at distributions centers related to governance of returns, destructions and general material management policy; retrieving distribution and inventory data in response to regulatory compliance actions (holds, recalls, etc.), including generating and verifying data within acceptable variance for distribution reports. Interfaces with Celgene internal sites and external manufacturing quality operations to ensure proper control of logistics and distribution of commercial products from site release through customer acquisition. Create and negotiate warehouse\/distribution\/logistics quality agreements, including development of key terms, performance indicators and compliance requirements. Ensure Celgene and contract distribution facilities are working in compliance with approved contracts and agreements. Act as a quality risk management responsible for Logistics in Americas. Prepare and implement long-term risk management and performance improvement plans for assigned facilities. Lead the evaluation, planning and implementation of process\/product changes within the regional supply chain and maintain compliance with global regulatory requirements. Assure the necessary quality and compliance steps are taken to prepare the Celgene supply chain to support new product launches, product in-license operations, new market and trading partner opportunities, new technologies and other supply chain related activities. Provide management with timely, reliable and well-structured information regarding facility performance including tracking of KPI\u2019s, variance analysis and contingency plans for corrective measures. Participate as appropriate in different quality\/business reviews (internal and with the vendors) and forums. Act as SME \/ QA liaison for GDP related topics in Celgene sites regulatory inspections and internal audits. EDUCATION AND EXPERIENCE Relevant college or university degree required; advanced degree preferred. WORKING CONDITIONS Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. #LI-POST 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.

15 days 10 hours ago

Celgene Corporation

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Sr Manager QA Logistics Americas Celgene Corporation - Summit, NJ, United States

   

Location: Summit, NJ

Company Profile:
Celgene is a multinational biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our mission 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. There are numerous 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 lymphocyte leukemia (CLL), non-Hodgkin's lymphoma (NHL), glioblastoma, and ovarian, pancreatic and prostate cancer.