QA Compliance & Systems Head
Contrato indefinido El Prat de Llobregat (Barcelona) Ámbito jurídico
Descripción de la oferta
Job Description
To lead, manage and supervise the activities of Quality Assurance Systems, Regulatory Compliance, Product Portfolio support and Technology Transfer. To become the focal point between Regulatory and Quality Assurance departments assuring a fluent communication and the adequate projects priority setting that will generate value to Novartis. Identify issues that might impact quality compliance and provide development of adequate corrective and preventive actions. Deputy Management representative to Site QA Head for ISO 13485 and designated notified body. Supplier quality oversight of third party providers and incoming deviations. Regulatory oversight of the Reg CMC functions in the plant. Deputy Escalation approver for the site. Deputy of Site QA Head as legally authorized company representative for contracts and financial agreements.
Position Title
QA Compliance & Systems Head
Perfil buscado
Minimum requirements
Basic training University degree in Pharmacy, Engineering, Chemistry or Microbiology Fluent in English and Spanish Preferred Training MBA. Specific Knowledge/Technical Knowledge / Skills (MU Full command in English Five years of progressive experience in Quality Assurance and/or a sterile manufacturing facility, in the pharmaceutical industry. Three years of managerial experience. Familiarity with all quality issues and production processes (GMP’s - EU and FDA, ISO)Preferred: More than five years of managerial experience in the quality assurance, quality control, validation or manufacturing, of sterile drugs Multinational environmental experience, familiar with EU and FDA GMP’s and medical device regulations Experience with technical standards (sterilization, aseptic processing, device and drug quality system standards) used by the Company
Job Type
Full Time
Country
Spain
Work Location
Barcelona
Functional Area
Quality
Division
Novartis Technical Operations
Business Unit
NTO QUALITY
Employment Type
Regular
Company/Legal Entity
Alcon Cusí S.A