QA Project Manager (m/w/d)

Key Requirements (Must-Haves)

• Solid experience in a GMP-regulated environment, ideally in QA roles within drug product manufacturing

• Strong knowledge of Quality Management Systems (QMS), including deviations, CAPAs, change controls, and batch disposition processes

• Excellent communication and cross-functional collaboration skills with the ability to interface with internal teams and external customers

Key Responsibilities

• Quality Operations & Documentation:
  Review and approve deviations, change controls, CAPAs, SOPs, batch records, and GMP documents. Support and represent QA during audits and inspections.

• Project-Based QA Oversight:
  Act as the QA point of contact for manufacturing projects, reviewing risk assessments, protocols, transfer documents, and providing disposition recommendations to the FvP.

• Customer & Batch Release Interface:
  Manage QA-related customer interactions (e.g., OOS, complaints, changes), support batch disposition activities, and act as delegate for the FvP for conditional release.