Overview The Senior Manager, Computerized Systems Validation & Veeva Systems is responsible for the configuration and maintenance of Veeva Vault applications and for the validation oversight to ensure the compliance, integrity, and reliability of computerized systems within the organization. This encompasses day-to-day Veeva systems operational management and project leadership with a focus on configuring, authoring, review, approval of system validation, infrastructure qualification documentation, and execution of protocols where applicable, in accordance with pharmaceutical industry regulations, guidelines, GAMP, latest industry practices and Shionogi processes. The senior manager collaborates with cross functional teams to facilitate successful system implementations, supports, or drives continuous improvement initiatives, ensures regulatory compliance, and fosters a culture of innovation and efficiency. Working in tandem with the CSV leadership team this role contributes to the broader organizational strategy, influencing decisions at the operational level and supporting the development of the overall validation and quality strategy. Ultimately, the senior manager is responsible for maintaining and advancing the quality and compliance standards of computerized systems across assigned projects. Responsibilities
Managing and overseeing system validation and infrastructure qualification, ensuring they are on schedule, within budget, and meeting regulatory requirements for assigned projects.
Configure and maintain Veeva Vault applications, including QMS, QualityDocs, RIM etc., to meet business requirements. Configurations will include but are not limited to:
Document Setup - Document Types Workflows, Lifecycles, etc.
Object Setup - Object Workflows, Lifecycles, Reports Setup etc.
User Setup - Security Profiles, Roles, Dynamic Access Control (DAC) etc.
Manage user roles, permissions, and access controls to ensure compliance with company policies.
Provide training and support to Veeva end-users, ensuring they have the knowledge and resources needed to effectively use the system.
Troubleshoot and resolve system issues in a timely manner, ensuring minimal disruption to business operations.
Review Change Control requests and assess impact to Veeva systems. Support the necessary computerized system validation activities for changes.
Perform gap analysis of systems, validation documentation, and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
Leads risk assessments and drives risk mitigation strategies to minimize potential issues in computerized system configuration, changes and validation.
Ensures that all validation activities adhere to relevant regulations, industry standards, and company policies.
Collaborate with cross-functional teams and support business to identify and implement process improvements, enhancing system efficiency and effectiveness.
Reviews, updates, and develops standard operating procedures (SOPs) and policies related to computerized system validation.
Serve as a Veeva system and validation expert to ensure deliverables have Quality and Compliance input from project initiation to final qualification.
Builds and maintains strong relationships with internal stakeholders, such as IT, project teams, and external vendors, to facilitate successful system implementations.
Lead/participate in supplier site Validation Assessments/Audits and work with suppliers to troubleshoot and improve systems and processes. Generate System Assessment/Audit Reports and follow-up with suppliers on implementation and closure of observations/recommendations identified in the report.
Participates in efforts to prepare for regulatory inspections, ensuring all documentation and processes are in compliance with regulatory requirements.
Effectively communicates validation program status, findings, and strategic plans to senior leadership and other relevant stakeholders.
Maintain up-to-date knowledge and understanding of Veeva system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures.
Other duties as assigned.
Minimum Job Requirements
Bachelor's Degree in a Scientific or Engineering discipline with a minimum of five (5) years of computerized system experience with IT compliance/validation/qualification activities.
Minimum of five (5) years of experience in an FDA-regulated, GxP-related environment.
Knowledge of industry standards for computer system design, implementation and validation.
Knowledge of cGxP/QSR , GAMP, ICH, EMA and FDA guidelines.
Experience with Veeva system configuration, validation and infrastructure qualification.
Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint, Access).
Must be capable of demonstrating results and accomplishments.
Ability to prioritize and successfully manage complex and competing projects within timeline.
Excellent oral and written communication skills.
Competencies
Ensuring all validation activities adhere to relevant regulations, industry standards, and company policies.
Proficiency in configuring and maintaining Veeva Vault applications, including QMS, QualityDocs, and RIM.
Managing and overseeing system validation and infrastructure qualification to ensure projects are on schedule and within budget.
Leading risk assessments and implementing risk mitigation strategies to minimize potential issues.
Performing gap analysis of systems, validation documentation, and practices, and recommending corrective actions.
Providing training and support to Veeva end-users to ensure effective system use.
Troubleshooting and resolving system issues promptly to minimize business disruption.
Reviewing Change Control requests and supporting necessary computerized system validation activities.
Working with cross-functional teams to identify and implement process improvements.
Effectively communicating validation program status, findings, and strategic plans to senior leadership and other stakeholders.
Other Requirements
This position does not have significant managerial and decision-making authority.
Ability and willingness to travel approximately 15% domestically and 10% internationally per year
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month
Essential Physical and Mental Requirements
Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Ability to travel via automobile and/or airplane.
Ability to view video display terminal images
Ability to operate a computer keyboard and telephone.
Ability to sit for extended periods of time - up to four (4) hours at a time.
Ability to lift, tug, pull up to fifteen (15) pounds.
To be considered for this position, you must apply and meet the requirements of this opportunity. We look forward to reviewing your resume & qualifications.DisclaimerThe job description is not designed to cover or contain a comprehensive listing of requirements, duties or responsibilities that are required of the employee. Other requirements, duties and responsibilities may change or be assigned at any time with or without notice. You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third-party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits. EEO Shionogi Inc. is an equal opportunity/affirmative action employer.All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law.It is the policy of Shionogi Inc. to undertake affirmative action in compliance with all federal, state, and local requirements to recruit a diverse pool of applicants and to ensure that our employment practices are, in fact, non-discriminatory.
