Celgene Director, Qualified Person Celgene Logistics in BOUDRY, NebraskaSwitzerland
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.
The Qualified Person Celgene Logistics exercises direct technical supervision over trading operations in Switzerland and abroad. He provides for the procurement, transport and dispatch of medicinal products in compliance with the Good Distribution Practice (GDP) as well as with the Market Authorisation documents and specifications. The Qualified Person is authorised to issue directives and may delegate tasks to his deputy as well as to Quality Assurance, Logistics Department and other persons in charge.
The Qualified Person Celgene Logistics is authorised to make decisions independent of the corporate Board within the scope of his competences.
The incumbent’s leadership will provide an environment that promotes and maintains a team-based collaborative culture.
Duties & Responsibilities:
Acts as Qualified Person on behalf of Celgene Logistics and is herewith responsible for the pharmaceutical and GDP-aspects of the company according to Art. 10 and Art. 14 of the Swiss Ordinance on Establishment Licenses (SR 812.212.1)
Leads and supervises the QA Logistics team in the International region (EMEA; APAC); supervises compliance with the requirements of GDP in the distribution of medicinal products in the International region
Supervises correct drafting, issuing and use of documents in relation to product storage, shipment and distribution, in particular of the Quality Management System (QMS)
Develops and maintains Quality Agreements with all transport companies and suppliers or Logistics Service Providers in the International region where Celgene Logistics is the contract giver; these agreements are GMP/GDP binding contracts which govern, and assure, our products are handled in compliance to regulations and corporate standards
Assists in the Quality/Compliance assessment of potential partner companies (Logistics Service Providers; LSP, wholesalers or Marketing Partners) or transport companies during the due-diligence process.
Supervises and assists in auditing of transport companies and other suppliers
Reviews, approves (or rejects) all process changes and any of specified contractors following the Corporate and Celgene Logistics processes
Secures necessary verification of transport conditions (qualification of routes), and implementation of monitoring or mitigation strategies as required
Secures full traceability of product transactions as required by GDP regulations, including product name, batch number, amount delivered from supplier to recipient at the respective Logistics Service Providers
Ensures compliant performance of product recalls or withdrawals in the International region; ensures regular testing of recall or withdrawal procedures through mock recalls
Assigns tasks to direct reports in accordance with their responsibilities and capabilities. Ensures continuous professional development and guidance to direct reports.
Responsible that self-audits are performed regularly for Celgene Logistics (may be delegated to the Compliance function of Celgene International Sàrl)
Investigation of logistics issues and deviations, including root cause analysis, and implementation of appropriate CAPAs; supports investigation of complaints and quality defects reported to Celgene International Sàrl, which may be related to transportation issues
Responsible for maintaining QA Logistics KPI’s/metrics and data for the periodic quality management review
EHS: Line Managers shall provide a safe and healthy work environment to their staff in areas under their control, and shall ensure compliance with relevant rules and legislation in those areas
Skills & Knowledge required:
BS, MS or PhD in science, pharmaceutical or medically related field.
Must have at least 7 years Quality experience in a Pharmaceutical company or other related industry.
In addition has preferably 3-5 years manufacturing and / or logistics experience in a Pharmaceutical company or other related industry, or 2-3 years direct accountability for the effective evaluation and release of drug products.
Expert level of Regulatory requirements and enforcement, especially GDP (EU / CH)
Demonstrated track record of successful working on multiple new product introductions, and life-cycle management.
Broad knowledge of Pharmaceutical Quality, Manufacturing and GxP practices; ability to establish cross functional partnerships and strategies; ability to understand/evaluate business and organizational issues to develop and implement solutions.
Leadership; ability to build trust and create collaborative environment and relationships; recognizes and effectively balances the interest and needs of QA with those of the organization.
Effective planning skills and recruitment skills to identify strong performers, hire adequate members of staff and establish a high performance organization; ability to anticipate resource needs and help establish priorities.
Strategic thinker who can balance near term objectives with long term goals and outcomes, evaluate risk and develop effective solutions through an integrated multi-disciplined decision-making approach.
Director, Qualified Person Celgene Logistics
Location: BOUDRY, NE, CH
Job ID: 17001132