Computer System Quality Subject Matter Expert (SME) for life cycle of Computerized Systems (CS) . Provides Quality oversight on CS with primary focus to implement and maintain an audit program designed to maintain IT enabled Biotech operations
at inspection ready state. This global role partners internally and externally to strategize best
possible solutions that meet industry norms as well as regulatory expectations. Provides
guidance to multiple sites on regulatory expectations, validation strategies and standards, risk
management strategies, and operational standards. Acts as global Quality Unit SME for CS
during regulatory inspections. Ensures compliance to applicable regulations and relevant
accepted industry guidance for computerized systems, through various activities such as
internal audits. Maintains regulatory knowledge and proactively assesses risk and mitigation
factors. Establishes and maintains standards for all CS Life cycle phases. Evaluates solutions
and proactively influences the implementation of standardized and harmonized solutions
• Design, implement and maintain audit program for GMP Computerized system across
Biotech sites. Organize, compile, edit, and prepare internal audit reports and follow corrective
actions to completion.
• Develop inspectional playbooks for common computer system compliance topics for use
• Global Computer System Quality SME:
o Determine and establish compliance requirements for a wide range of computerized
systems, consistent with Corporate Directives and regulatory expectations. Influences
standard and simple solutions globally.
o Must understand complex relationship of enterprise systems, manufacturing systems, and
laboratory systems and the user and data interfaces between these systems. Work with
COEs to define, influence and implement global standards.
Completes projects in a timely manner and with high quality and accuracy.
• Apply a Risk Based approach to systems and processes. Ensures that system updates and
timelines are appropriate based on assessed risk.
• Maintains complete focus on regulatory landscape, proactively monitoring trends and
changes and influencing Biotech sites to adapt as necessary.
• The ability to identify issues of significance, communicate complex issues to global and site
leadership, provide multiple alternatives to the solution of complex problems and the ability to
provide guidance in their implementation.
• Uses resources across site and across departments to assure timely investigations of high
quality. Leads teams to provide highly scientific evaluation of issues intended to mitigate
business and compliance risk while maintaining product supply. Manages non-routine projects of moderate to high complexity.
Bachelor’s degree in a scientific or technical field, preferably in the biological sciences. An
advanced degree is preferred. 10 years of GMP related experience in pharmaceutical,
biologics, medical device, or related industry, along with knowledge of applicable US and
foreign regulations. At least 4 years of direct experience in Manufacturing and/or Quality in a
GMP-regulated industry or an equivalent combination of education and experience. Focused
experience with GMP computerized systems and 5+ years of experience with
• Excellent working knowledge of regulatory requirements including 21 CFR Part 11, Annex
11, PIC/s guidelines and other cGMPs.
• Excellent people skills to convince motivate and encourage customers/stakeholders to
understand and accept his/her recommendations, especially with borderline issues.
• Proven ability to express views and opinions, listens well and accept conflicting points of
view. Proven ability to lead cross functional teams.
• The ability to independently recognize opportunities and the need for business and process
• The ability to self motivate to a high level of productivity. The ability to multitask and support
• Strong written and oral communication skills, excellent presentation and influencing skills
• Effective technical/business communication skills and ability to interact and influence
different levels of management, locally and globally. Proven ability to work with diverse
environments and cultures globally.
• Strong experience in risk strategies, harmonized solutions and industry standards for
• Proven expertise in application of electronic records and signatures, GAMP, global
regulatory compliance and SDLC, with extensive experience in interfacing with regulatory
Bachelor’s degree in a scientific or technical field, preferably in the biological sciences. An,10 years of GMP related experience in pharmaceutical,,At least 4 years of direct experience in Manufacturing and/or Quality in a,5+ years of experience with auditing/inspection activities, Excellent working knowledge of regulatory requirements including 21 CFR Part 11, Annex