Reporting to the Director of IT - Computer Systems Validation, the Sr. Manager is accountable for IT validation activities including the supervision of professional level staff. The Sr. Manager will provide leadership, guidance, and management services for IT QC/validation initiatives across business units. The Sr. Manager will liaise with IT Management to execute the Company’s overall IT validation strategy by assisting in the development and coordination of computer systems validation activities. The Sr. Manager will also assist and guide the career growth and development of professional level staff.
The Sr. Manager will work regularly with Project Managers and respective leaders from Internal Audit, Business Unit QA, IT Operations, IT Architecture, and HR organizations. The Sr. Manager will provide co-ordination for communication and training projects that cross multiple business units that require interdisciplinary teams to assess and manage IT validation aspects within a highly regulated environment. Provide support for internal and external computer system validation audits across business units.
- Develop, implement, and own a risked-based validation methodology and harmonized SDLC.
- Work closely with IT leaders to implement a common Computer System Validation and SDLC methodology in each IT functional area.
- Review progress toward implementing the common SDLC methodology regularly with IT leaders, technical teams and internal clients to make modifications as necessary.
- Identify and implement a common set of tools for conducting and executing computer systems validation (SDLC) that will reduce the total cost of compliance, while protecting the assets of the company.
- Recommend, monitor, evaluate, manage, and execute proper controls for the Company's computer systems to ensure the reliability of applications and infrastructure, as well as the integrity of data and safety of subjects.
- Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current IT CV techniques.
- Design and monitor performance metrics program.
- Analyze and identify trends in IT performance metrics for improvement of IT initiatives.
- Deliver technology, standards, and processes in accordance with department objectives and goals.
- Provide training materials and co-ordinate training sessions related to computer system validation topics.
- Prepare validation models and test strategies for IT initiatives, and present to project teams.
- Enforce Covance standard testing methodologies, procedures, and practices as they relate to systems validation.
- Ensure that applications and systems are in compliance with established Covance IT standards.
- Provide direction to assure that IT applications and infrastructure components possess the necessary level of testing, and required documentation to comply with applicable GxP regulations and customer requirements/expectations.
- Liaise with the IT ComplianceAudit function to develop and implement a continuous improvement model of the Company’s validation methodology and SDLC.
- Provide and co-ordinate auditsupport for client and regulatory inspections.*
- Coordinate responses to client and regulatory observations and provide metrics regarding audit activities.*
- Educate and trains IT staff, business associates, and CV Project Leads as to the IT validation methodology, and their respective responsibilities.
- Create training materials and provide training opportunities for computer system validation issues across business units.
- Lead teams by providing clear articulation of direction and expectations.
- Champion the application of quality principles in IT and business processes through training, meeting and team facilitation, communication programs and team building activities.
- Develop communication plans and strategies to ensure effective change management regarding computer system validation topics.
- Assist in performance management and engagement of each individual team member as a cohesive unit.
- Provide coaching and support to direct reports and team members.
- 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 Managementexperience – 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
- 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.)
Job Number 2018-20881