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Vice President, Head of Small Molecule Manufacturing - Switzerland  

Company managed [?] Still accepting applications
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Posted on : 01 May 2017

Project Description

Description:
  • The Vice President, Head of Small Molecules Manufacturing is responsible for the overall supervision of our small molecules commercial manufacturing in our company.
  • The incumbent is responsible for internal and external capabilities worldwide, including planning, forecasting and demand.



Responsibilities
  • Responsible for planning, supply chain and launch activities for all small molecules. 
  • Technical responsibilities for commercial API and Drug Product production. 
  • Responsible for ensuring that defined standards, including cGMPs and approved manufacturing process/product specifications, are upheld in all aspects. 
  • Reviews all process changes at the site and any of specified contractors in collaboration with QA. 
  • Collaborate with plant management in resolution of any production problems, provide analytical trouble-shooting support. Assure effective corrective actions to roots causes. 
  • Assure that adequate staff, equipment and facilities are available to complete activities for product manufacturing within required timelines. 
  • Assure effective training programs are in place for all manufacturing personnel. 
  • Supervise all production activities at third parties and/or in house in the limit of the agreements in place 
  • Responsible for negotiations for new or existing contracts involving manufacturing capabilities 
  • Assure site readiness for regulatory inspections including providing support for inspection preparation activities in QC and contractor sites, as needed. 
  • In collaboration with the Global Process and Development group ensure product transfer to manufacturing sites. 
  • Develop a small molecules manufacturing strategy including back-up solutions and business case when relevant 
  • Collaborate and support the EHS committee 
  • Know about the policy of security at work and about laws concerning health and security of the workers. 
  • Maintain company’s knowledge on industry standards and trends in participating in regulatory agencies forums, seminars etc.. 
  • Develop the annual budget for the relative areas on responsibilities 



Minimum Requirements
  • BS or MS in science or medically related field. 
  • Expert level of Regulatory requirements and enforcement, especially ICH/GMP. 
  • Must have at least 10 years manufacturing experience in a Pharmaceutical company. 
  • Must have 3-5 years Quality experience in a Pharmaceutical company or other related industry. 
  • Demonstrated track record of success working on multiple new product introductions, and life-cycle management. 
  • Broad knowledge of Pharmaceutical Quality, Manufacturing and GLP/GCP/GMP practices; ability to force 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. 
  • Effective planning skills and recruitment skills to identify strong performers hire adequate members of staff and establish a high performance organization; ability to anticipate resources needs and help establish priorities. 
  • Ability to develop effective, flexible relationships with others; understands the business agendas and perspectives of others; recognizes and effectively balances the interest and needs within the organization. 
  • 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.