SUMMARY: This role is responsible for leading the strategy, governance, and execution of validation
and data integrity programs across equipment, utilities, computerized systems, and GMP manufacturing
processes within the USWM-CT production facility. The Manager, Validation and Data Integrity, provides
leadership to the Validation team, ensuring compliance with cGMP, global regulatory expectations, and
USWM policies. This role will drive lifecycle validation programs, oversee change control and risk
management processes, support regulatory inspections, and ensure the manufacturing facility remains
in a state of continuous compliance and inspection readiness.
DUTIES AND RESPONSIBILITIES:
The following reflects management's definition of essential functions for this job but does not restrict
the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this
job at any time due to reasonable accommodation or other reasons.
• Lead the development, approval, and maintenance of Validation Master Plans (VMPs) and Data
Integrity Governance Plans using a lifecycle approach for equipment, utilities, computerized
systems, and GMP processes.
• Define and oversee validation and data integrity deliverables including URS, FS/DS, risk
assessments, IQ/OQ/PQ protocols, Part 11/Annex 11 assessments, data flow maps, and
summary reports.
• Direct the planning and execution of validation and qualification activities, ensuring deviations,
investigations, data integrity issues, and technical issues are resolved promptly and effectively.
• Establish and maintain data integrity controls aligned with ALCOA+ principles across
computerized systems, manufacturing processes, and quality systems.
• Manage cross-functional coordination with QA, Manufacturing, Process Development, QC, Facilities, and IT teams to ensure validation activities support operational readiness.
• Apply Quality Risk Management principles and lead the use of risk assessment tools (e.g., FMEA)
to support validation decisions and prioritization.
• Identify opportunities for continuous improvement and implement enhancements to validation
practices, data integrity controls, documentation quality, and operational efficiency.
• Ensure all validation and data integrity work is performed in accordance with applicable
regulations, cGMPs, industry guidelines, and USWM policies and procedures.
• Provide oversight and support for ongoing qualification, requalification, data integrity
remediation and validation activities at internal and external manufacturing sites.
• Lead and approve change control impact assessments for process, equipment, utilities, facilities,
and computerized systems, ensuring validated state and data integrity are maintained.
• Maintain inspection readiness and serve as a subject matter expert (SME) during regulatory
inspections, internal audits, and external audits.
• Participate in routine operational meetings (CAPA, Deviation, Change Control) and provide
Validation leadership and decision-making support.
• Collaborate on aseptic process validation strategies, ensuring compliance with facility design,
cleanroom requirements, and aseptic manufacturing standards.
• Lead, mentor, and develop the Validation team, ensuring strong technical capability, effective
workload management, and high performance.
QUALIFICATIONS:
Required
• Bachelor's Degree in Science or related technical field.
• Minimum of 7-10 years of validation, or related experience in biotechnology or pharmaceutical
industries, including leadership or supervisory experience.
• Strong understanding of cGMPs, regulatory guidance, and multinational biopharmaceutical/cell
therapy regulations.
• Deep knowledge of global regulatory requirements for Clinical and Commercial GMP
computerized systems validation, including GAMP 5, ASTM-E2500, ICH guidelines, USP, 21 CFR
210/211, and 21 CFR Part 11.
• Experience developing and implementing data integrity programs and remediation strategies.
• Experience with Quality Risk Management principles and performing risk assessments using
tools such as FMEA.
• Proven ability to lead cross-functional teams and manage multiple complex projects in a
fast-paced environment.
• Strong organizational, communication, and leadership skills with the ability to influence at all
levels.
• Experience with quality systems supporting validation and data integrity activities (Document
Management, Training, Deviation Management, Change Control, CAPA).
• Hands-on experience with equipment qualification, utilities, automation, single-use
technologies, closed systems, and cold chain/cryogenic technologies.
• Knowledge of facility/cleanroom design, aseptic processing, and validation of aseptic operations.
• Proficiency in Microsoft Word, Excel, PowerPoint.
Desirable
• Experience with Calibration manager databases, Electronic Lab Notebooks, Quality Management
systems, Validation Data Acquisition systems (ie Kaye, Ellab, TempTale), Building Management
systems, Document Control software
• Experience with leading the start-up, validation, and licensure of manufacturing facilities.
• Strong knowledge and direct experience with aseptic manufacturing and the validation of aseptic
processes (aseptic process validation).
• Experience working with cell and gene therapies or biologics products.
• Experience working with external parties and/or leading cross-functional teams
PHYSICAL DEMANDS:
• Frequently required to stand
• Frequently required to walk.
• Frequently required to sit.
• Frequently required to talk or hear.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision and ability to adjust
or focus
WORK ENVIRONMENT:
• The noise level in the work environment usually is quiet.
• Aseptic Gowning is a requirement when executing validation work on the floor.
