Manager, Validation & Data Integrity
USWM, LLC
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.
Job description
Duties and Responsibilities
- 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
Requirements
- 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.
Company overview
USWM, LLC is a pharmaceutical manufacturing company operating in the healthcare sector. As a pharmaceutical entity, the company is involved in the development, production, and distribution of pharmaceutical products and medications. Pharmaceutical manufacturing companies like USWM, LLC play a critical role in the healthcare ecosystem by ensuring the availability of essential medicines and therapeutic treatments. These companies typically engage in various stages of pharmaceutical production including research and development, formulation, quality control testing, and regulatory compliance. The pharmaceutical manufacturing industry requires adherence to strict quality standards and regulatory guidelines to ensure product safety and efficacy. USWM, LLC operates within this highly regulated environment, contributing to the supply chain of pharmaceutical products that serve healthcare providers, patients, and the broader medical community.