Senior Manager, Computerized Systems Validation & Quality Assurance - Shionogi Inc.

The Senior Manager, Computerized Systems Validation & Quality Assurance is responsible for validation oversight to ensure the compliance, integrity, and reliability of computerized systems within the organization. This encompasses day-to-day operational management and project leadership with a focus on 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.

The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed. The duties and responsibilities listed are intended to provide a general overview of the position and may change over time based on the needs of the organization.

• Managing and overseeing system validation and infrastructure qualification, ensuring they are on schedule, within budget, and meeting regulatory requirements for assigned projects.
• 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.
• Leads risk assessments and drives risk mitigation strategies to minimize potential issues in computerized system validation.
• Ensures that all validation activities adhere to relevant regulations, industry standards, and company policies.
• Support continuous improvement initiatives, optimizing validation processes, and implementing best practices to enhance efficiency and effectiveness.
• Reviews, updates, and develops standard operating procedures (SOPs) and policies related to computerized system validation.
• Serve as a validation expert to ensure deliverables have Quality and Compliance input from project initiation to final qualification.
• Work closely and collaboratively with various business partners including Information Technology and system owners to implement new computerized systems, system upgrades, or system modifications effectively and efficiently.
• 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 quality system requirements as they apply to computerized system in accordance with GxP’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.
• Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines.
• Knowledge of industry standards for computer system design, implementation and validation.
• Knowledge of cGxP/QSR , GAMP, ICH, EMA and FDA guidelines.
• Experience with application system 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.
• May be required to travel 10% domestically and 5% internationally.

Essential Physical 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 < 18” away from face for extended period of time – up to four (4) hours at a time.
• 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.

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.