Sr Director Global Quality - Fort Dodge Animal Health

Location: Overland Park, KS
Categories: Director
Website: http://www.wyeth.com

Position Description

POSITION OVERVIEW:
Responsible for providing oversight and guidance on quality assurance and control to manufacturing sites with respect to compliance related issues in the development or manufacture of new animal vaccines. The position actively leads or supports intra-divisional projects, investigations, and inspections to assure compliance with regulatory and business requirements

RESPONSIBILITIES:

·Responsible for supporting the development of Global Quality Policies that assure consistent and compliant activities at operations sites worldwide.
·Represent Global Quality Assurance and site quality on New Product Registration activities (e.g. New Biological Product Teams as championed by R&D).
·Function as project leader/coordinator on critical projects defined within quality, business, and manufacturing strategy.
·Interact with Commercial in coordinating resolution of product-related issues, including product defect, product supply and the need for product improvements.
·Interact with worldwide manufacturing sites in troubleshooting biological quality concerns relating to regulatory compliance, product quality, customer service, or new product introduction. Provide technical input and coordinate availability of resources from other FDAH sites.
·Provide critical analyses and investigations as required by Senior Management and draft reports as required in support of quality and business strategies.
·Assist in the preparation of the Global Quality budget and monthly metrics and reports.
·Communicate directly with international site managers and staff as needed to meet objectives.

BASIC QUALIFICATION
· Graduate degree in Microbiology, Chemistry, Engineering, Biochemistry or DVM
· Minimum of 10 years experience in development and manufacture of biological products.
· Knowledge of quality management necessary to implement effective QA/QC projects in support of animal vaccine manufacturing.
· Experience in managing a quality assurance or quality control unit as defined under US and International Veterinary Biological Good Manufacturing Practices (GMP) regulations.
· Must be able to analyze and troubleshoot complex systems, and manage the required constructive actions to achieve the desired goal.
· Ability and willingness to travel both domestically and internationally.

How to Apply

https://wyeth.recruitmax.com/main/careerportal/candidate_update.cfm