Assoc. Dir., Info. Sys. Audit

As an Associate Director, you will report to the department director and assist in developing and directing Global Compliance Auditing (GCA) - IS to maintain and improve the compliance standards of all regulated Wyeth Information Systems by auditing internal systems, software and hardware vendors, contract research organizations (CRO's) and contractors. A deep understanding of applicable FDA, ICH, EMEA, GMP, GLP, GCP standards is expected as related to IS/IT. You will direct the development and implementation of audit plans for conduct of audits globally. This will include: 1) assessing the audit request and audit assessments, 2) assessing the appropriateness of a desk audit vs. an on site audit, 3) supporting the auditor during the audit conduct, 4) supporting the timely audit report through reviewing the report for accuracy and appropriateness, 5) and assuring the appropriate distribution of the audit report. This position will periodically require travel alone or with the audit staff for support. You will direct support for the training, supervising and the coordination of all audit staff in the development of the audit staff's competency to perform quality, structured audits of computerized systems and ensure the audit staff members are qualified, well trained and competent to perform all audits including non-standard or non-routine audits on short notice. You will facilitate resolution of audit findings and use the information to improve Company's compliance and continued adherence to applicable regulations and to track corrective actions. You will monitor global regulatory requirements for change and proactively implement updates to all audit plans and assess risk to Company Objectives, collaborating with Company Senior Management to assure compliance to all regulations and guidelines and actively proposing solutions and plans to Management for these risks. You will assist in leading the GCA-IS department to develop and maintain global ways of working to ensure consistencies with the other GCA departments in the standardization of audit conduct and audit reporting. You will also seek the collaboration of other Wyeth groups for auditing opportunities throughout the Company. The position will require domestic and international travel of 30 - 40%.This position requires a Bachelor's Degree in the Sciences and 12 years of diversified Technical Compliance/Audit experience (7 years with a Master of Science Degree), as well as proven managerial responsibility in a Pharmaceutical Quality group. A background in Business Management, Quality Management and Regulatory Affairs, Information Sciences or Engineering with experience in Computer Science is required. A Master of Science Degree is a plus. Previous experience in multiple Scientific/Medical and Pharmaceutical Regulatory disciplines is needed. Excellent demonstrated managerial, organizational, interpersonal, communication and problems solving skills are necessary. Management and conduct of the Scientific and Pharmaceutical Compliance Auditing Practices with expertise in Regulatory Inspectorate Expectations is essential. Training and experience in domestic and international GxP, Regulatory Affairs/Quality Assurance, in Government Regulations, (FDA, ICH, EMEA, etc.) is expected. Regulatory Compliance auditing with proven success in identifying and resolving non-compliance is also required.Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
address below.For more information, visit our website at