Validation Manager

Location: NC-RTP, US Contract Type: Regular Full-Time Area: GENERAL MANAGEMENT Req Id: 547588

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.

This role follows a hybrid work schedule, with 2 days per week in the office (RTP) and 3 days per week working remotely.

Manager, Validation

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.

PRIMARY 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.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

EDUCATION AND EXPERIENCE

• 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.

OCCUPATIONAL DEMANDS FORM # 34: Work is performed in an office and a laboratory /manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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 and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.

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Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

Location: NORTH AMERICA : USA : NC-RTP: USNC0001 - RTP NC-Headquarters

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