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Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:

SR. VALIDATION MANAGER

Charlotte, North Carolina (on site 5 days a week)

This Is What You’ll Do:

Develops company validation standards, procedures, policy and guidelines to provide oversight of the validation program, including Validation Master Plans Responsible for or oversees the development and execution of GxP computerized systems (hardware, software, and regulated reports) validation protocols and documents consistent with Good Automated Manufacturing Practice (GAMP) and Blood Establishment Computer System (BECS) guidelines, including: Validation Plans, Installation/Operational/Performance Qualifications (IQ/OQ/PQ), Test Cases, Traceability Matrices, Validation Summaries Responsible for or oversees the development and execution of equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP), including: Donor center processing equipment Laboratory testing equipment Freezers Refrigerators Temperature mapping of rooms and equipment Responsible for or oversees the development and execution of process validation protocols and documents consistent with FDA and EU guidelines. Responsible for reviewing internal and external validation documents to evaluate for completeness and leverage opportunities, including: Design Specifications Configuration Specifications Technical Specifications Interface Specifications Qualification documents/Test Cases Contributes to the development of end User Requirement Specifications documents and assists with assessing risk related to proposed changes. Evaluates validation results and approves final validation reports. Oversees the review, approval, and impact assessment of IT infrastructure and computerized system change controls, and Donor Center Automation change controls. Leads deviation investigations identified during the validation process and ensures timely resolution of all nonconformities. Responsible for the co-development of project plans and validation schedules, along with the Project Management Office, to ensure strategic alignment and sufficient resource planning. Defines and develops Validation Schedule(s) to ensure that all equipment and computer hardware/software are periodically reviewed and assessed for revalidation, in compliance with written standards, procedures, policies and guidelines. Provides direction regarding validation policy and procedures to all OPI departments, including IT, donor center personnel, laboratory and plasma warehouse, and contract engineers. Responsible for ensuring compliance with Octapharma Plasma, Inc. standard operating procedures (SOPs), international (EU), federal (FDA), and state and local regulations, customer specifications, and GAMP guidelines.
Performs statistical analysis of validation data, as required, and reports to Senior Management regarding process improvement opportunities. Represents QA Validation on projects teams and during regulatory inspections. Performs audits of current or prospective vendors. Manages and defines expectations and schedules for external/contract validation vendors. Develops QA Validation staff by providing feedback and training plans, and evaluates staff performance. Develops group and individual goals that are in line with company and departmental objectives. Provides a comprehensive leadership example to staff, promoting a positive work environment.

This Is What It Takes: 

Bachelor’s degree in IT, life science or related field and minimum of five (5) years’ experience with software/equipment validation. Minimum of two (3) years’ supervisory/management experience. Minimum of two (3) years’ related project management experience. PMP preferred. Minimum of two (2) years’ experience in a FDA-regulated environment. Must be fluent in application software validation, as it relates to 21CFR Part 11 Compliance, BECS, and GAMP requirements. Experienced in developing and approving system implementation project test cases and other project related documents, such as SOPs, user and functional requirements. Demonstrated understanding of IT system change management. High proficiency with Microsoft Office applications required. Demonstrated verbal, written and interpersonal communication skills. Demonstrated flexibility to changing priorities. Demonstrated problem-solving skills. Must be willing to travel, as necessary; approximately 10%.

Do Satisfying Work. Earn Real Rewards and Benefits.

We’re widely known and respected for our benefits and for leadership that is supportive and hands-on.

Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time

More About Octapharma Plasma, Inc.

With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.

INNER SATISFACTION.

OUTSTANDING IMPACT.