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:
Occupational Demands Form # 9: 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.
