Manager, Life Sciences - Computer Systems Validation
Business Title: Manager, Life Sciences - Computer Systems Validation Requisition Number: 40449 - 57 Function: Advisory Area of Interest: State: NJ City: Short Hills Description:
Known for being a great place to work and build a career, KPMG provides audit, tax and advisory services for organizations in today's most important industries. Our growth is driven by delivering real results for our clients. It's also enabled by our culture, which encourages individual development, embraces an inclusive environment, rewards innovative excellence and supports our communities. With qualities like those, it's no wonder we're consistently ranked among the best companies to work for by Fortune Magazine, Consulting Magazine, Working Mother Magazine, Diversity Inc. and others. If you're as passionate about your future as we are, join our team.
KPMG is currently seeking a Manager in Customer & Operations for our Management Consulting practice.
Support KPMG's Quality Compliance Remediation Practice by leading teams to deliver computer systems validations (CSV) projects ? FDA, Part 11
Provide regulatory compliance and computer validation guidance and support to KPMG clients
Participate is fast paced engagements, with a team of 3-5 staff, supporting subcontractors and off-shore resources
Assist in developing Software Development Life Cycle (SDLC) CSV strategy, templates and standard operating procedures
Create system validation deliverables (validation plan, user requirements, risk analysis, test protocols, validation reports)
Perform a risk analysis; Plan and coordinate the validation testing and perform system audits for compliance with best practices and regulatory requirements
A minimum of five years of Life Sciences Industry experience in computer system validation
Bachelor's degree in Computer Science, Engineering, Business Information Systems, Information Management or other quantitative discipline with specialization from an accredited college or university
Awareness of various types of enterprise platforms used within Medical Device & Pharma industries for running their business: Quality Management Systems, Document Management Systems, and Training Systems
Experience and good understanding of the regulations and industry standards such as ISO, ITIL, COBIT, GAMP, Prince 2 and PMBOK
Background in management consulting with a track record of successful engagement management and experience in delivering client presentations
Travel may be up to 80-100%
Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future
KPMG LLP (the U.S. member firm of KPMG International) offers a comprehensive compensation and benefits package. KPMG is an affirmative action-equal opportunity employer. KPMG complies with all applicable federal, state and local laws regarding recruitment and hiring. All qualified applicants are considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other category protected by applicable federal, state or local laws. The attached link contains further information regarding the firm's compliance with federal, state and local recruitment and hiring laws. No phone calls or agencies please.
GL: 4 GF: 15292
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.