Job Posting We are seeking a Senior Computer Systems Validation Manager in Indianapolis, IN.
The Senior CSV Manager is responsible for establishing and executing computer systems validation for the global organization.
Because of our passion and drive, Covance attracts the kind of people whose contribution has resulted in our exceptional growth. Once a part of our talented team, our employees stay at Covance to work in an environment that encourages career development, allows them to work alongside respected colleagues on challenging projects and provides a diverse global culture.
There is no better time to join us! Education/Qualifications • 8+ years experience in a FDA (GXP) regulated industry (i.e. such as pharmaceutical, medical device, or biotechnology)
- Bachelor’s Degree required (ex. science based, operations research, technology, etc.); MS/MBA preferred.
- Industry related certifications preferred (e.g. PMP, CQE, CQM, etc.) Experience • 6+ years experience leading/managing teams, developing strategies, execution of projects, 4+ years partnering/guiding clients at management levels, 2+ years leading large IT validation projects.
- Familiar with various validation methodologies (SDLC), and their implementation in an IT organization
- Knowledgeable of regulatory compliance requirements in the pharmaceutical and drug development industry (GxPs)
- Implementing and maintaining risk based validation model & strategies
- Creative approach to resolving technical issues, and balancing business needs with validation requirements
- Program & Project Management experience – ability to plan, organize, and execute work across multiple initiatives to drive delivery of validation commitments
- IT business process development and improvement
- Proven ability to build strong teams; and develop professional level staff
- Demonstrates self motivation to lead teams on a unified validation strategy, while achieving department goals, objectives, and initiatives
- Ability to interact with all levels within the organization
- Customer relationship management
- Ability to manage multiple priorities
- Ability to provide leadership and training to others
- Strong interpersonal skills and ability to command respect of others
- Exceptional verbal, written, presentation, and interpersonal skills EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer. (M/F/D/V). Your confidentiality and privacy are important to us.
Covance Inc. is a drug development services company providing a range of early-stage and late-stage product development services on a...