Validation Manager

GRIFOLS, S.A.•NC-RTP, CA

6d•Hybrid

About The Position

Ensures current Good Manufacturing Practices (cGMP), FDA/Grifols Quality Systems, and other applicable regulatory requirements are met throughout the evaluation, review and disposition of validation and quality assurance/control documentation. This role follows a hybrid work schedule, with 2 days per week in the office (RTP) and 3 days per week working remotely.

Requirements

Bachelor's degree in a scientific field.
Typically requires 8 years of quality and validation experience in a cGMP and/or IT environment.
Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures, validation standards and guidelines, and standard operating procedures.
Excellent quantitative and analytical skills.
Excellent oral and written communication skills.
Strong critical thinking and problem solving skills.
Ability to identify errors and provide corrective action.
Ability to work with others in a team environment.
Knowledge of Microsoft Office applications and computer applications used in the Donor Centers.

Responsibilities

Manage department resources and prioritize work to ensure timelines are met.
Develops cGMP operating procedures that relate to process, information systems, and equipment validation/qualification.
Ensures compliance with SOPs upon implementation. Supports Donor Center and Field Quality/Operations in investigations and proposes additional corrective actions as required.
Supports Change Control and Supplier Quality.
Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
Oversees the validation process to ensure validation approaches are current to regulatory expectations and standards within the industry.
Develop, implement, and maintain current library of validation and qualification templates.
Write test cases to validate manufacturing processes, information systems, equipment, user requirements, and functional designs.
Execute test cases as needed.
Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. This includes donor center processes and information systems.
Analyze validation data to ensure acceptance criteria are met.
Write validation summaries.
Ensure milestones and timelines are met on assigned projects.
Evaluate effectiveness of validation/qualification protocols.
Evaluates adequacy of corrective actions.
Evaluates completeness of validation reports.
Oversees the evaluation of processes, systems, and individual center equipment needs and final approval process.
Identification and determination of actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service.
Tracking and monitoring process/system failures/events.
Tracking and monitoring of equipment calibration due dates and calibration failures/events.
Monitoring and trending of nonconformance related to validation equipment failures.