Technical QA Manager – Facilities and Systems

Roche

. QA oversight of qualification and validation activities for GMP-relevant facilities and equipment, with a focus on solid dosage forms and packaging, as well as simple CSV systems (GAMP 5 Categories 1 and 3) .

Posted 10/15/2026full-timeBasel • SwitzerlandMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in QA oversight for GMP-relevant facilities and equipment, with a strong focus on solid dosage forms, packaging, and data integrity requirements. Proficient in conducting root cause analyses and driving optimization within quality processes while ensuring compliance with global quality standards.

Highest-signal resume keywords

GMP ComplianceFacility QualificationData Integrity StandardsHealth Authority InspectionsRoot Cause Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Qualification PlansCAPAsSOPsChange ManagementDeviation ManagementRisk AssessmentsCSV SystemsGMP RequirementsPharmaceutical Industry ExperienceQuality Assurance

Soft Skills

Team-Working SkillsCommunication AbilitiesInfluencing AbilitiesCuriosityOwnership

Industry Keywords

GMPCGMPAnnex 15Annex 11Solid Dosage FormsPackagingQuality ManagementPharmacyLife SciencesEngineering

Tech Stack

Tools & technologies

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About the role

Key responsibilities & impact

QA oversight of qualification and validation activities for GMP-relevant facilities and equipment, with a focus on solid dosage forms and packaging, as well as simple CSV systems (GAMP 5 Categories 1 and 3)
Support for implementing data integrity requirements and maintaining the “Right to Operate” through end-to-end cGMP activities
Review and approval of GMP documents such as qualification plans, CAPAs, SOPs, change and deviation management documentation, and risk assessments
Conduct in-depth root cause analyses to resolve complex problems
Drive optimization and improvement activities within IMP Quality
Work closely with stakeholders to achieve shared goals
Represent the area of responsibility during health authority inspections and internal audits

Requirements

What you’ll need

University degree in engineering, chemistry, life sciences, pharmacy, or a comparable qualification
At least 5 years of experience in the pharmaceutical industry, including at least 2 years in QA
Extensive practical experience in facility and equipment qualification (Annex 15) and CSV (Annex 11)
In-depth understanding of global quality and GMP requirements
Experience with current data integrity (DI) standards
Experience with health authority inspections and internal audits
Strong team-working skills, as well as excellent communication and influencing abilities
Curiosity and a willingness to take ownership
Fluent German and English, both written and spoken

Benefits

Comp & perks

Equal Opportunity Employer
Opportunities for personal and professional growth
Open dialogue and an appreciative, inclusive company culture