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LO
Lonza
15d ago

Senior QA Specialist/QA Project Manager(m/w/x)

Visp
Full-timeOn-siteSenior

Description

You will lead quality oversight for biopharmaceutical manufacturing, ensuring every product meets strict cGMP standards while driving compliance across cross-functional project teams.

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Requirements

  • •Degree in Biotechnology, Biology, or Chemistry
  • •Experience in biopharmaceutical manufacturing or QA
  • •Background in cGMP and biotechnological processes
  • •Experience representing Quality and Compliance
  • •Communication skills and regulatory agency interaction
  • •Preferred experience with TrackWise, LIMS, DMS, SAP
  • •Excellent English and advantageous German knowledge

Education

Bachelor's degree

Work Experience

approx. 4 - 6 years

Tasks

  • •Define quality requirements for manufacturing processes
  • •Ensure compliance with cGMP standards and regulations
  • •Represent Quality and Compliance in cross-functional teams
  • •Provide full QA oversight for specific products
  • •Manage manufacturing activities for commercial biopharmaceutical supply
  • •Represent QA during new biotech tech transfers
  • •Coordinate QA interests throughout various project phases
  • •Make quality decisions in internal and external meetings
  • •Review and release SOPs and batch records
  • •Approve material specifications and quality risk assessments
  • •Manage deviations, CAPAs, and change requests
  • •Assess product changes for regulatory filing relevance
  • •Support investigations into customer product complaints
  • •Develop new quality and compliance strategies
  • •Generate annual product quality reviews
  • •Support regulatory inspections and customer audits

Tools & Technologies

TrackWiseLIMSDMSSAP

Languages

English – Business Fluent

German – Basic

Benefits

Bonuses & Incentives

  • •Performance-based compensation programs

Career Advancement

  • •Agile career

Informal Culture

  • •Dynamic working culture

Purpose-Driven Work

  • •Inclusive and ethical workplace
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