Associate Director, Quality Assurance

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary:

Provide leadership, expertise, support, and direction in the areas of Quality Assurance and Validation.  Manage, develop and implement validation protocols and test procedures to ensure appropriate regulatory requirements, company standards, and industry practices are met.  Responsible for the development and direct/indirect oversight of associates for the achievement of the company’s quality goals.

 

 

Primary Responsibilities:

• Develop and implement a robust tracking and trending process that provides information to the organization to improve overall quality processes.
• Oversee trending analysis regarding inputs from functional business areas, to include monitoring organizational performance by gathering relevant quality systems data and producing statistical reports.
• Oversee the Corporate Corrective and Preventive Actions (CAPA) Process promoting process improvement efforts from an organizational perspective.
• Provide risk management oversight regarding internal and external complaint handling.
• Perform quality assurance evaluation of new/revised standard operation procedures (SOPs).
• Partner with appropriate internal departments to establish and oversee quality requirements from external suppliers.
• Provide resources and support for supplier qualification classification and approval, including the management of supplier corrective action request resolution.
• Provide oversight of the organizational equipment validation process.
• Promote quality achievement and performance improvement throughout the organization.

 

 

Knowledge, Skills, and Abilities:

• Excellent problem solving skills and communication skills (i.e., verbal, written, and electronic). 
• Ability to successfully interface with all levels of management and customers or suppliers in various functional modalities to assure a consistent supply of quality goods and services. 
• Highly developed skills in leadership, negotiation, and influence. 
• Ability to successfully interface with individuals from scientific, production, regulatory, and executive management backgrounds to achieve quality and business goals and objectives. 
• Detailed knowledge of all customer and regulatory body requirements. including State and Federal regulations, European Health Authority requirements,
• Occupational Safety and Health Administration (OSHA) regulations and the Clinical Laboratory Improvement Act of 1988 ("CLIA"), etc.

 

 

Education and Experience:

• Bachelor's Degree in science or a related field required.                                                  
• Requires a minimum of 8 years of Quality Assurance experience working with trending analysis Corrective and Preventive Action development and process improvement.  Additional experience working with cross functional teams as well as with suppliers and distributors in a corporate quality or validation role.  Project or technical leadership experience required.  Supervisory or management experience preferred.

 

 

Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.   Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

The estimated pay scale for Associate Director, Quality A