Manager, Quality Risk

Manager, Quality Risk

Location: NC-RTP, US Contract Type: Regular Full-Time Area: MANUFACTURING

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: Supervises a team of Quality Risk specialists and is responsible for ensuring organizational adherence to corporate quality processes, including quality management systems reviews, deviation/CAPA management, data integrity assessments, and risk management assessments. Collaborates with corporate functional areas to ensure processes are managed in a GXP compliant manner through identification and management of Quality and Compliance risks. Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems through the management, analysis, and monitoring of quality data and metrics and associated quality systems to ensure a holistic and complete input to Biomat USA Quality systems.

Primary Responsibilities:

• Maintains oversight of all Quality Risk Management processes and Quality Assurance KPI metrics including Quality Risk Assessments, Data Integrity Risk Assessments, Impact Assessments, and the Quality Metrics Dashboard.
• Responsible for ensuring key stakeholders are aware of identified risks and proposes a plan to mitigate these risks.
• Works closely with senior management to understand donor center, as well as corporate quality and metric data and its relationship to business processes and controls.
• Tracks and trends inspection/audit observations. Analyzes data, recognizes areas of improvement, and offers solutions to enhance compliance.
• Leads QAS team in assuring corporate quality functions are routinely reviewed and properly analyzed to drive improvement and mitigate risks.
• Manages Corporate Deviation Reporting for Plasma Procurement, ensuring records are adequately written and timelines are met.
• Reviews Corporate deviations and tracking / trending data to assist with continuous improvement.
• Initiates Change Requests and writes Standard Operating Procedures as needed based on identified improvement opportunities.
• Manage the team that is responsible for the KPI application / QUINTET application and database and oversee the generation and distribution of periodic analytics reports.
• Oversees the completion of Data Integrity Risk Assessments/performs Data Integrity Risk Assessments as needed.
• Oversees developing additional mechanisms for assessing data and quality analytics within the organization.
• Serves as the Quality Risk Assessment Administrator.
• Manages and leads activities of QAS team, including work duties, training, and scheduling.
• Travels up to 25% or greater if demand is required.

Knowledge, Skills, and Abilities:

• The incumbent must have the ability to write clear, concise, logical responses to regulatory authorities.
• Must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
• Must know the European Pharmacopoeia (EP) and other European Guidelines as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).
• Must have strong interpersonal skills with the ability to communicate effectively with people from other cultures and other points of view.

Education and Experience:

• A BS degree with a preference for an MS degree in a life science field.
• Typically requires a minimum of 4 years of related experience.
• Project or technical leadership experience required.
• Supervisory or management experience preferred.
• Experience with Quality systems and Regulatory Compliance is desired.
• Plasma industry experience is beneficial.

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.
• Frequently walks.
• Occasionally bends and twists neck.
• Light to moderate lifting and carrying objects with a maximum lift of 30lbs.
• Frequently drives to site locations with occasional travel within the United States.
• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Interacts with others, relates sensitive information to diverse groups.

Learn more about Grifols