IT Validation Manager/Senior Manager: Alexion Pharmaceuticals,Inc.

Responsiblities:

The IT Validation Manager/Senior Manager is responsible for developing the procedures and documentation to support the validation of IT automation, and Alexion’s GxP and business systems. The incumbent will implement and maintain a life cycle approach to validation, and support the system maintenance and change control programs in accordance with GxP/SOX requirements. This position will provide technical input on validation requirements for IT systems in accordance with business strategies and Quality requirements. The incumbent may direct the work of subordinate staff, IT consultants/vendors to ensure execution according to GxP/SOX requirements and approved documents.

The individual in this position is expected to have :

• An in-depth understanding of cGMP, GLP, and GCP regulations as applied to the pharmaceutical industry, laboratory, and manufacturing environments.
• A thorough knowledge of data acquisition systems, data storage techniques, and reporting requirements for operating in a validated environment is essential.
• Knowledge of IT controls for Sarbanes Oxley (SOX) is preferred.
• This position requires the individual to have an understanding of basic hardware / software configurations typical of laboratory instrumentation, network operations and enterprise systems.
• The individual in this position will be able to organize his/her own work, without supervision, and can organize, implement and coordinate project activities in adherence to strict business timelines and milestones.
• This individual is able to provide concise written updates and tracking on his/her tasks and monitor assigned projects.
• Ability to effectively communicate, both verbally and in a written format, is required.
• Excellent presentation skills are required.
• Knowledge of current office software applications, IT methodologies, practices, and techniques is essential.
• Ability to troubleshoot hardware/software systems, and document impact and corrective actions for maintaining system integrity and validation status, is required.
• Knowledge of manufacturing, laboratory, Quality, and IT automation systems, Part 11 compliance and current regulatory requirements is essential.
• Strong organizational, interpersonal and communication skills with a team-oriented approach to project management and problem resolution is required.

Requirements

• B.S. degree in Computer Science, Engineering, or related scientific field
• 4-8 years experience in oversight of IT automation and validation in a bio/pharmaceutical environment, or an equivalent combination of training and experience.

About Alexion Pharmaceuticals

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Employing more than 500 people worldwide, Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. Soliris^(R) (eculizumab) is Alexion's first marketed product for patients with paroxysmal noctural hemoglobinuria (PNH) a rare, debilitating and life-threatening blood disorder defined by the destruction of red blood cells, or hemolysis. Soliris is approved in the U.S. and Europe in 2007, and Canada and Australia in 2009. Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development.

Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, and a 401(K) plan.

Alexion is an Equal Opportunity/Affirmative Action Employer.