Vice President, Head of Small Molecule Manufacturing - Switzerland
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- 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.
- 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
- 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.