The Sr. Manager, IT Quality will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements.
The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving.
Essential Functions and Responsibilities
Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.
Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.
Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements
Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications.
Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports.
Coordinate implementation validation/qualification strategies and serve as the subject matter expert.
Present project status reports to management as well as project teams.
Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes.
Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report.
Support internal, client, and regulatory audits and inspections.
Generate or review/update computer system related policies, procedures, templates, forms, etc.
Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures.
Performs other quality system related duties as necessary.
Bachelor’s Degree in a Scientific or Engineering discipline with eight (8) + years of computerized system experience with IT compliance/validation/qualification activities.
Eight (8) + years of experience working in an FDA-regulated, GxP-related environment
Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.
Comprehensive knowledge in Software Validation and Data Integrity Principles.
Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations.
Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.
Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.
Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)
Knowledge of Software Risk Management Principles and tools.
Knowledge and proven ability working with Risk Management methodologies and tools.
Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.
Experience with application system validation and infrastructure qualification.
Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus.
Experience with writing and approving Standard Operating Procedures and Quality Standards.
10% travel required.
Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint).
Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams.
Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers.
Solid organizational and time management skills, proven project management, presentation and facilitation skills.
Innovation and strategic compliance skills including looking internally and externally for best practices.
The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities.
The ability to enable and drive change while being focused on internal and external customers.
Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines.