QMS Specialist, Lausanne

The QMS Specialist works within the Quality Assurance team to support and manage the Quality Management System in a pharmaceutical manufacturing environment.

The role ensures compliance with cGMP standards and regulatory requirements (Swiss, EU, FDA) and focuses on maintaining and improving key quality processes such as documentation, training, deviation management, and change control.

Key Responsibilities Quality Systems Management

Act as SME administrator for Veeva eDMS and eQMS

Manage QA processes:

Documentation&controlled copies

Training systems

Deviation&change control

Archiving&retention

Documentation&Training

Oversee

document lifecycle

(creation, review, approval, release)

Manage

document change control process

Maintain

training matrices

and assign training

Develop and deliver

GMP&QMS training

Ensure proper onboarding (training, systems access, documentation)

Operational Support

Support users in

daily use of quality systems

Act as

first point of contact

for troubleshooting

Escalate issues to global teams when needed

Manage controlled copy issuance and tracking

Compliance&Continuous Improvement

Ensure compliance with

cGMP and internal procedures

Drive

continuous improvement initiatives

within QMS processes

Maintain

KPIs and dashboards

to monitor quality system performance

Support and participate in:

Internal audits

Regulatory inspections (Swissmedic, international authorities)

Experience&Skills

Minimum

2 years in a GMP environment

Hands‑on experience with

Veeva required

Strong communication skills (written&verbal)

Ability to work in a

compliant, pragmatic, and team-oriented way

Language

Fluent in English and French (mandatory)

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