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 9/29/2026full-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 compliance with data integrity standards. Proven ability to conduct root cause analyses, manage qualification documentation, and represent quality assurance during health authority inspections.

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 RequirementsAnnex 15Annex 11

Soft Skills

Team PlayerExcellent CommunicationInfluencing SkillsCurious MindsetOwnership

Industry Keywords

Pharmaceutical IndustryCGMP ActivitiesQuality AssuranceStakeholder CollaborationInternal Audits

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)
Supporting the implementation of data integrity requirements
Maintaining the Right to Operate through end-to-end cGMP activities
Reviewing and approving GMP documents, including qualification plans, CAPAs, SOPs, change and deviation management documentation, and risk assessments
Conducting in-depth root cause analyses to resolve complex issues
Driving optimization and improvement activities within IMP Quality
Working closely with stakeholders to achieve shared goals
Representing 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 hands-on experience in facility and equipment qualification (Annex 15) and CSV (Annex 11)
In-depth understanding of global quality and GMP requirements
Knowledge of current data integrity (DI) standards
Experience with health authority inspections and internal audits
Strong team player with excellent communication and influencing skills
Curious mindset and willingness to take ownership
Fluency in written and spoken German and English

Benefits

Comp & perks

Equal Opportunity Employer
Personal and professional development in a culture that encourages self-expression, open dialogue, and authentic connections
Collaboration in a global environment with more than 100,000 employees
Access to innovative, life-changing healthcare solutions with global impact