Job Description: Job Purpose:
To ensure that the auditing activities in the region are effectively carried out. To ensure, through independent audits and continuous improvement of quality standards, that sites and their activities meet sanofi and Regulatory requirements
Leads the Global Quality Audit Group for Americas region in conducting their activity on all sites, internal and external.
. Evaluation and Maintenance of Quality & Regulatory Compliance
. Definition, Implementation and Maintenance of Quality Systems & Quality Product Standards
. Management of interfaces with Regulators & Health Authorities, Clients and Suppliers
. Development and improvement of Quality
Ensures that Sanofi sites and third parties achieve, maintain and improve the current level of GMP/GDP compliance through:
. Determination of quality and compliance deficiencies
. Monitoring of corrective actions
. Providing independent advice, recommendations and solutions
. Identification and communication of emerging GMP, Regulatory and Industry trends identifying, promoting and communication of best practices".
Main professionnal contacts (internal / external):
Manufacturing and Quality Operations (internal)
US FDA and EMEA (internal)
Minimum Science Graduate or equivalent. At least 15 years relevant experience in Quality Assurance/control, Management, manufacturing and/or Pharmaceutical Research. Management experience necessary. Good knowledge of American and Latin American regulatory requirements and cultures.
? Fluent English , Spanish is a plus
Specific experience and knowledge:
? Requires in-depth knowledge of theories and practices within region and worldwide in pharmaceutical technology for all product forms and related fields such as zoning concepts, environmental monitoring, utilities, quality systems, etc.
? Requires strong understanding of sanofi-aventis departments, systems, strategies and how they interact. Of particular importance includes in-depth knowledge of R&D, Vaccines (sanofi-pasteur), Industrial Affairs and Generics.
? Requires extensive experience and expertise in global and regulatory laws, requirements and expectations, including, but not limited to, FDA CFR, EU and WHO requirements.
Essential behavioral competencies:
? Ability to build human relationships and a basis of mutual trust between audited sites and the Global Quality Audit group as well as other Global groups and Operational Heads
? Ability to overcome discrepancies in interpretation of quality and compliance requirements
? Ability to influence and negotiate areas of GMP regulatory requirements and expectations
? Ability to understand the workings of and form close relationships with key customers
? Ability to enter into highly different cultural and regulatory backgrounds worldwide
? Ability to present audit findings in a clear, concise and diplomatic way to the site and all levels of Management
? Flexibility in approach and ability to adapt to changing circumstances when required