Computerized System QA Manager

Coopers Group; Oberwallis; On-site; CHF 110,000 - 170,000; Full time

Job summary

Coopers Group in Visp seeks a Computerized System QA Manager to establish and maintain a robust quality framework for GxP computerized systems, electronic records, and data integrity. You will ensure validation, operation, and oversight across CSV activities and related systems.

You will lead Data Integrity governance, support inspections, and drive continuous improvement with cross-functional teams while aligning with EU GMP Annex 11 and FDA 21 CFR Part 11 standards.

Qualifications

• Bachelor's or Master's in a related discipline.
• 5+ years' QA/CSV/Data Integrity in GMP environments.
• Experience leading or managing projects or teams.

Responsibilities

• Lead system validation across lifecycle and governance for CSV.
• Maintain data integrity, audit trails, and back-up/recovery.
• Ensure compliance with EU GMP Annex 11 and 21 CFR Part 11.
• Prepare for inspections and customer/regulatory audits.

Skills

CSV governance

Data Integrity

GxP QA oversight

Regulatory compliance

Leadership

Documentation practices

Education

Bachelor's or Master's in Computer Science/Engineering/Pharma

Tools

MES

LIMS

DMS

SAP

TrackWise

DeltaV

LMS

Job description

Location: Visp

Initial 3 Months Contract with possibility to extend till 6 Months

The Computerized System QA Manager is responsible for establishing and maintaining a robust quality framework for GxP computerized systems, electronic records, electronic signatures, data governance and data integrity. The role ensures systems are validated, operated and maintained in compliance with EU GMP, FDA, Annex 11, GAMP 5 and applicable regulatory expectations. Additionally this role supports the lifecycle management of data not only electronically but paper based as well as the cultural maintenance of the Data Integrity and Good Documentation Practices within the site.

Responsibilities

• Must possess a comprehensive understanding of Computerized Systems Quality Assurance and Data Integrity programs.
• Provide site leadership for Data Integrity governance, strategy, risk management and continuous improvement initiatives.
• Act as the primary QA authority for computerized system validation (CSV) activities throughout the system lifecycle.
• Ensure GxP computerized systems remain in a validated state through effective oversight of validation, periodic review and change management activities.
• Lead and coach QA and non QA professionals supporting computerized systems and data integrity activities.
• Review and approve validation plans, user requirements, risk assessments, specifications, test protocols and validation reports.
• Provide QA oversight of computerized systems provided as a service to the site including MES, LIMS, DMS, SAP, TrackWise, DeltaV, historian systems and supporting infrastructure.
• Assess and approve changes, deviations, CAPAs and investigations related to computerized systems and data integrity events.
• Drive compliance with EU GMP Annex 11, FDA 21 CFR Part 11, Data Integrity guidance and GAMP 5 principles.
• Lead site inspection readiness for computerized systems and represent QA during customer audits and regulatory inspections.
• Establish and monitor key performance indicators for CSV and Data Integrity programs.
• Partner with business functions to ensure effective governance of electronic records, audit trails, access management and backup/recovery processes.
• Support digital transformation initiatives while ensuring compliance and patient safety.

Requirements

• Bachelor's or Master's degree in Computer Science, Engineering, Pharmaceutical Sciences, Biotechnology, or a related discipline.
• Minimum 5 years of experience in Quality Assurance (QA), Computerized Systems Validation (CSV), IT Quality, Data Integrity, or a related quality/compliance function within a GMP-regulated pharmaceutical, biotechnology, or cell & gene therapy environment, including leadership or project leadership responsibilities.
• Strong expertise in computerized system validation and analytical instrument qualification, including validation lifecycle activities (URS, IQ/OQ/PQ, risk assessments, traceability, testing, validation reports) and risk-based validation approaches.
• Extensive knowledge of Data Integrity principles, governance, testing, and regulatory expectations, including compliance with EU GMP, FDA requirements, Annex 11, 21 CFR Part 11, GAMP 5, and other applicable GxP regulations.
• Proven experience reviewing and approving validation documentation, deviations, CAPAs, change controls, risk assessments, investigations, and quality records.
• Hands-on experience with regulated GxP systems and platforms such as MES, LIMS, DMS, SAP, TrackWise/TrackWise AQWA, Kneat, DeltaV, Learning Management Systems (LMS), laboratory systems, and manufacturing or automation platforms.
• Experience in deviation management, CAPA management, quality event investigations, root cause analysis (5 Whys, Ishikawa/Fishbone), change control, and risk assessment methodologies.
• Demonstrated experience supporting regulatory inspections, audits, inspection readiness activities, and customer audits.
• Strong understanding of quality systems and compliance processes, including GxP documentation, SOP authoring and management, training management, gap assessments, supplier qualification, batch record review, product quality review, and quality metrics reporting.
• Experience managing multiple validation and qualification activities simultaneously, including prioritization of high-volume protocol execution and documentation review.
• Proven ability to lead cross-functional teams, drive continuous improvement initiatives, support business process optimization, and effectively collaborate with Quality, IT, Manufacturing, Engineering, Automation, and Laboratory stakeholders.