Computerized System QA Manager (m/w/d) — Coopers Group AG
- Location
- Sion
- Contract
- Full-time
- Posted
- 2 days ago
Full description
The Computerized System QA Manager will provide strategic and operational leadership for Computerized Systems Quality Assurance and Data Integrity across the site. The role partners closely with IT/OT, Automation, Manufacturing, Engineering, Quality Control, Quality & Compliance and global functions to ensure computerized systems remain compliant, inspection ready, and aligned with business objectives.
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.
Job profile
- Engineering - Quality Management
- Wallis
- Contracting
- Part Time, 100%
- Immediately - 3 to 6 months
- CSV, Quality Assurance, Data Integrity
Requirements
Engineering - Quality Management
Contracting
Part Time, 100%
Immediately - 3 to 6 months
CSV, Quality Assurance, Data Integrity
Questions about this listing
What salary does Coopers Group AG offer for this role?
The original listing does not state a salary. Our estimate for this role and sector in Sion is CHF 83'500 - 126'500 gross per year — an estimate, not a figure communicated by Coopers Group AG. The calculator on this site converts a gross salary into your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Coopers Group AG offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Coopers Group AG during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Valais?
EU/EFTA residents living in the border zone of the country adjoining Canton Valais can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Valais's cantonal migration office or with HR during the application.
How do I apply for this position at Coopers Group AG?
Use the "Apply now" button on this page — it links directly to Coopers Group AG's original listing at coopers.ch, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
