CSQA Compliance Lead (m/f/d)

Datalynx AG; Basel; Hybrid; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A prominent pharmaceutical company in Basel is seeking a CSQA Compliance Lead (m/f/d) to ensure compliance with regulatory standards and QA processes. The ideal candidate will have extensive experience in IT Quality and Business QA, proficiency in both Agile and Waterfall methodologies, and be adept in evaluation and risk assessments within QA projects. This role involves reviewing deliverables, supporting audits, and managing Change Requests. Candidates should possess a BA/BS in Computer Science, with strong negotiation and problem-solving skills, and proficiency in relevant IT tools.

Qualifikationen

• 5-10 years of experience in Industry.
• 5 years of experience in CSV.
• Fluent in English; German is a plus.

Aufgaben

• Review CSV deliverables to ensure compliance with GxP standards.
• Evaluate IT Change and Problem Tickets from a QA perspective.
• Support general QA activities like audits and SOP reviews.

Kenntnisse

IT Quality

Business QA

Agile methodologies

Waterfall methodologies

Problem solving

Good negotiation skills

Calm demeanor

Ausbildung

BA/BS in Computer Science or equivalent

Tools

Google Suite

Microfocus ALM

Veeva QMS

Service Now

Jobbeschreibung

CSQA Compliance Lead (m/f/d)

For our client, a well-known pharmaceutical company in Basel, we are looking for a CSQA Compliance Lead (m/f/d)

Background

The perfect candidate has experience in either IT Quality or Business QA as a CSV expert. This person has experience working with both Agile and Waterfall project delivery methodologies and understands ITIL, as well as Quality Change and Problem Management. This person is familiar working as a QA Owner for Change, CAPA, and Deviations.

General Information

Start date: asap
latest Start Date: 01.10.25
Planned duration: 12 months
Extension (in case of limitation): possible
Workplace: Basel
Workload: 80-100%
Home Office: up to 2 days a week

Tasks and Responsibilities

• Review CSV deliverables to ensure compliance with GxP and internal standards
• Evaluate IT Change and Problem Tickets from a QA perspective
• Support general QA activities like audits, SOP reviews, and inspections
• Perform risk assessments for IT systems and planned changes
• Review test plans and reports for completeness, traceability, and compliance
• Assess and manage Change Requests throughout the full change lifecycle

Must Haves

• BA/BS in Computer Science or equivalent experience in Industry (5-10 years)
• 5 Years experience in CSV
• IT skills required: Google Suite, Microfocus ALM, Veeva QMS is a +, Service Now
• Language skills: English Fluent and German would be a plus
• Soft skills required: calm, good negotiator, understanding of complex problem
• solving,understanding on GMP a requirements

Contact

Jan Schmitz-Elsen
Talent Acquisition Consultant
[phone]

We look forward to receiving your online application with your CV!

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