Manager/Sr. Manager, Validation - CSV & Data Integrity

Job Summary

The Manager/Sr. Manager, Validation - CSV & Data Integrity is responsible for ensuring that computerized systems supporting GxP operations are appropriately assessed, validated, implemented, controlled, and maintained throughout their lifecycle. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GxP software applications. Supports the Data Integrity program to ensure that GxP data is reliable, complete, accurate, attributable, secure, and maintained in accordance with regulatory expectations and company quality standards. Collaborates with cross functional teams, ensuring compliance with regulatory requirements, and drives best-in-class validation practices that support our Quality Management System and operational excellence.

Job Responsibilities:

Computer Systems Validation

• Manage the organization's Computer Systems Validation (CSV) strategy, governance framework and establish risk-based approaches for validation of GxP computerized systems.
• Establish validation standards, templates, procedures, and best practices for the organization. Ensure validation strategies are aligned with business requirements, quality risk, regulatory expectations, and company policies and procedures.
• Provide CSV leadership for implementations, upgrades, patches, configuration changes, integrations/interfaces, data migrations, system replacements and retirement/decommissioning
• Ensure appropriate validation oversight throughout the computerized system lifecycle.
• Oversee development and execution of validation deliverables, including Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ Protocols, Test Plans/Scripts, Traceability Matrices, Validation Summary Reports, etc.
• Ensure computerized systems remain in a validated/compliant state and validation activities are appropriately planned, documented, reviewed, and approved before systems are released for GxP use.
• Manage multiple concurrent validation projects, priorities, risks, manpower, and dependencies.
• Manage and execute periodic reviews and validation status activities.

Data Integrity

• Support the establishment of controls to protect GxP data throughout its lifecycle.
• Support and continuously improve the organization's GxP Data Integrity program.
• Serve as a subject-matter expert for ALCOA+ and data lifecycle management.
• Establish risk-based approaches for identifying, assessing, and mitigating data integrity risks.
• Ensure audit trail functionality and review processes are appropriately assessed during validation.
• Support the risk-based audit trail review program.
• Support data integrity assessments, user access reviews and audit trail reviews across GxP systems, processes, equipment, and laboratory/manufacturing environments.
• Partner with QA, IT and business process owners to mitigate and address identified data integrity vulnerabilities.

Management/Leadership

• Provide leadership and mentoring to CSV professionals, consultants, and cross-functional project teams.
• Promote a strong culture of data ownership, accountability, and integrity.
• Establish and monitor CSV KPIs, quality metrics and management reporting.
• Monitor regulatory and industry trends ensuring the CSV program aligns with applicable regulatory requirements and industry expectations.
• Provide leadership and ensure CSV aspects of deviations, investigations, CAPAs, and change controls are appropriately addressed.
• Provide CSV SME leadership during audits and regulatory inspections and ensure remediation of CSV audit observations.

Special Work Requirements

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

Education/Certifications/Licenses

• Bachelor’s degree in Engineering, Computer Science or related discipline.

On-the-Job Experience

• 10+ years of Computer System Validation experience
• Strong understanding and hands on CSV experience in implementations, upgrades, patches, configuration changes, integrations/interfaces, data migrations, system replacements and retirement/decommissioning projects
• Collaborate and build strong partnerships across QA, QC, Manufacturing, Engineering, IT, Operations, and business functions.

Knowledge, Skills and Experience

• Ability to communicate effectively and collaboratively with employees of all experience levels from Genezen, with project team members and other contract firms
• Excellent communication skills (interpersonal, presentation, verbal and written)
• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
• Excellent technical writing skills
• Demonstrates good analytical problem-solving skills
• Excellent project management skills
• Strong working knowledge in Microsoft Office (Word, Excel, Visio, etc.) and Adobe Acrobat
• Strong working knowledge of GxP regulations including 21 CFR Parts 11, 210/211, EU GMP Annex 11, data integrity guidances, ICH guidelines, and GAMP 5 best practices with the ability to assess compliance risks

Compensation Range

The compensation range for this position is dependent upon experience level of the successful candidate. The ranges are as follows:

• Manager- $130,000-$150,000
• Sr. Manager- $150,000-$170,000

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Rarely lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail

Genezen's Cures Value-Based Competencies

• Committed to Science: We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
• Urgency in action for the patients: We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
• Resilience & Grit in operations: We are committed to overcoming challenges, learning from failures, and persistently striving for success.
• Execute with Excellence & Integrity: We are dedicated to delivering quality results and upholding ethical principals.
• Solutions driven for our partners: We are committed to being a proactive, collaborative, creative and open-minded partner.

Genezen's Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary
• Share Appreciation Rights
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Additional Details

• Nothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• This position requires a criminal background check.
• Genezen is an Equal Opportunity Employer.
• Genezen participates in EVerify.
• Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.

Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts.

Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.

Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.