North American Quality Director

Über die Tätigkeit

With the exciting stage of its growth, Fagron is now looking to recruit a highly experienced leader to the role of North American Quality Director. This is a critical leadership position responsible for the establishment of the strategic direction, achievement of major objectives, and overall leadership of the Quality function within our North American business.

The Quality Director will be based at the North American head office in Austin and will report to the Business Leader of North America. He/she will work closely with the Global Quality Director and with the Chief Operations Officer. 

To accomplish this, he/she has to work on a diversity of tasks, which are listed in a number of job specifications.

Tasks and Responsibilities

• In collaboration with the Global Quality Director, develop metrics and reports with meaningful data related to activity levels, quality measures, and regulatory compliance.
• Ensure that the quality standards meet or exceed global and local guidelines such as but not limited to GDP, GMP, FDA  
• Ensure GDP/GMP compliance through internal and external audits, supported by Fagron’s quality team
• Act as Fagron’s Quality representative in meetings with governmental bodies
• Work with the Global Quality Director to align NA and Global quality standards with the aim to establish a common global standard at global, regional and local level 
• Manages the selection, training, development, and performance of assigned staff to retain a motivated, professional workforce for the department.
• Responsible for setting and executing short and long term goals and objectives.
• Identifies training and/or development opportunities that will assist the employee in achieving enhanced job performance.
• Builds support and alliances between and among departments to promote Quality culture.
• Support local quality departments to take action on audit findings, to reinforce compliance or remedial action on any unsatisfactory findings 
• Ensure data integrity in all quality related documentation to meet regulatory compliance.
• Ensure that procedures and systems are in place for Supplier Qualifications and that these procedures are harmonized across North America in line with Global recommendations.
• Create and govern Fagron’s manual and supportive documents such as SOPs, SLA, CAPA, RRA, Etc. at regional and local level
• Support Business Development units with regards to RFQ, RFI and RFQ responses for all quality and quality process related matters
• Support client facing activities such as audits and high-level meetings