Manager, Infrastructure Quality Assurance

SUMMARY:

Manager, Infrastructure Quality Assurance

This position can be located in either Washington, DC or Ashburn, VA

The Manager Infrastructure Quality Assurance provides oversight and guidance for the design, development, testing and implementation of information technology (IT) infrastructure systems supporting software applications. The Manager promotes an effective risk-based approach to validation, recognizing an appropriate balance between quality, cost and timelines. Will be familiar with the practical application of relevant FDA regulations, FDA guidance, AABB, IEEE and industry best practice.

RESPONSIBILITIES:

Provides guidance and subject matter expertise to IT teams on QA methodologies and processes, educates them on their responsibilities /accountabilities for the purpose of achieving first time right, on-time and quality deliverables.

Develop and oversee units metrics program for evaluating the results of measures and recommending process improvements to managers. Develop and maintain a Quality Assurance System for unit, ensuring the department adheres to that system. Mentor, direct and oversee staff to ensure appropriate participation in development and documentation reviews. Interact and oversee vendor related activities as defind by vendor contracts.

Maintain current knowledge of quality and industry standards, analyzing effects of changing requirements on BIT QRM operations. Participate and guide staff to particiapte in IT management of problems, helping to prioritize problems, recommending solutions and overseeing corrective action progress.

Develops, modifies, applies, and maintains standards for quality operating methods, processes, systems and procedures. Provides coordination and guidance in preparation of technical appraisals of programming languages and systems, computational software and related technology, and the integration of computers into the overall functions of scientific computation, and data acquisition, transmission, and processing. Ensures that corrective measures meet acceptable reliability standards. Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives. Ensures that project and process control documentation are compliant with requirements, objectives and/or contract. Reviews software design, change specifications, and plans against contractual and/or process requirements. Reviews include applicable specifications, materials, tools, techniques, and methodologies. Performs or directs verification of software requirement allocations, traceability, and testability.

QUALIFICATIONS / CAPABILITIES:

? Bachelors Degree in Computer Science, or similar, or equivalent experience • At least five years experience, to include at least three years supervisory experience in a related management role preferably Quality Assurance, Quality Engineering or Quality Control • Good management skills • Experience with different operating systems, such as XP, Windows 2003, AIX, Solaris, etc. • Knowledge of relational databases - Oracle 9i and above. • Good verbal and written communication skills. • Knowledge and experience in quality and regulatory affairs with a working knowledge of the Quality Systems Regulations (21CFR 820) • Strong working knowledge and experience of IT infrastructure • Good management skills • Knowledge and experience in quality and regulatory affairs • Ability to apply concepts, technology and industry best practice in areas of quality and regulatory management • Responsible for compliance with CFR, FDA guidelines, Red Cross directives and project requirements. Such regulations, guidance, standards and best practices include: ** US FDA 21CFR Part 211 ** US FDA 1CFR Parts 600, 606 and 610 **FDA Guidance • General Principals of Software Validation? **FDA Guidance • 21CFR Part 11, Electronic Records, Electronic ? Scope and Application? • FDA Guidance • Blood Establishment Computer System Validation in the Users Facility? (Draft) • The GAMP® Good Practice Guide (including GAMP 5) • The GAMP® Good Practice Guides including: ** • IT Infrastructure Control and Compliance? ** • Global Information Systems? ** • A Risk-Based Approach to Electronic Records and Signatures? ** • Testing of GxP Systems?

The American Red Cross National Headquarters is an Equal Opportunity/Affirmative Action Employer

Please refer to job code 8012BR when responding to this ad.

Category:	Information Technology
	> Quality Assurance
Location:	Washington, DC
County:	District Of Columbia County
ZIP Code:	20001
Pay Rate:	Open
Job Terms:	full time
Company:	The American Red Cross
Phone:	email only please
Fax:	email only please