Requisition ID BIR09508
Job Description Duties
• Oversees and directs the overall validation compliance of GxP equipment, systems and utilities. This includes all Columbus, Ohio locations and Reno Distribution.
• Acts as main liaison to Boehringer-Ingelheim Corporate for
· Equipment and Systems Validation Interactions (includes networking, visits, written communication and phone contact).
· Change Review Committee (international products)
• Directs the development and maintenance of standard operating procedures and guidelines for Change Management, Validation and Qualification policies, standards, procedures, programs, templates and vendor auditing.
• Provides guidance on the development of appropriate qualification and testing strategies. Provides input on development activities to ensure that the principles of validation and qualification are captured and maintained throughout the lifecycle.
• Directs and manages the staff of Change Management/Validation Services
• Develops and administers area budget
Qualifications
• B.S./B.A. required. Degree in Science or Science related field with strong Computer Information Systems and Validation knowledge
• Minimum of 10 years managerial experience required in a Pharmaceutical (preferred) or related business (chemicals, food, or other similarly-regulated environment)
• Demonstrated competence in regulatory compliance, validation and quality assurance.
• Demonstrated ability to guide the creation and establishment of Global Policy through influence and negotiation.
• Demonstrated ability to organize and analyze statistical and technical data.
• Demonstrated knowledge of Validation principles and regulations for equipment, utilities, facility, process control systems and computerized systems in a pharmaceutical or related FDA regulated industry.
• Demonstrated accomplishments in effectively implementing cGxP and Validation regulations within the pharmaceutical or related FDA regulated industry.
• Possess excellent communication and interpersonal skills with the ability to influence/ persuade individuals to gain acceptance of an idea or plan. Ability to utilize active listening skills to understand the concerns or reasoning in order to be responsive, gain trust, and build strategic relationships. Ability to recognize and capitalize on cultural diversity.
• Computer skills required (for example, tracking record databases like Trackwise and MS Access, MS Word, MS Excel, and MS VSS.
• Demonstrated knowledge of business and management principles involved in planning, resource allocation and leadership technique.
• Solid knowledge of financial and budgeting processes preferred.