QA MANAGER CMO MANAGEMENT BIOTECH

10 MaiFach­ver­ant­wortung100%

6-12 Month Contrator role in BIG Biopharma EU region

QA MANAGER CMO MANAGEMENT BIOTECH

Our customer is an innovative pharmaceutical company located in Switzerland. Intense R&D activities gave rise to an exciting pipeline of new promising drugs, many of which successfully reached commercialization stage. Support the Development and Operations team’s mission to define and deliver a most trusted manufacturing and distribution network. We are looking for an experienced QA Manager to provide Quality oversight of Contract Manufacturing Organizations (CMOs) performing key manufacturing steps in Europe. You will take responsibility for tasks related to compliance gap remediation, Risk Assessments/ FMEA and Quality improvement initiatives.

Your Challenges:

  • Provide oversight of routine operations at CMOs in support of intermediate product manufacturing
  • Closing and remediation of detected gaps in collaboration with CMO
  • Develop and track KPIs for internal and external performance in relation to batch release activities, occasionally batch review and release
  • Partner with CMO Quality to ensure a robust batch release process
  • Oversee batch disposition status for European patients and ensuring availability and completeness of documentation required for final drug product release (QP release)
  • Review and follow up of CMO deviation investigations, CAPA. Independent review of controlled documents (Master records, protocols, reports, SOPs)
  • Support in review and approval of internal investigations and CAPA affecting the CMO
Your experience with biological manufacturing and related documentation will help you to prioritize and successfully manage complex and competing tasks. You need to show detail orientation with expertise in problem solving and solid decision-making abilities.

Your Profile:
  • B.Sc, M.Sc. Biochemistry, Biology, Microbiology, Chemistry
  • 2-6 years of experience in Biotech-Pharma QA, QC or Manufacturing
  • Knowledge of GMP requirements and CMO collaborations
  • 10% travelling to CMO (EU) and some on site presence
You will work independently and reliable with regards to quality and timeframes. See look for openness to work in cross functional teams with very good verbal and written communication skills. Fluent in English, German is an asset!

Working place is between German and French speaking area in Switzerland.

Haben wir Ihr Interesse geweckt? Dann freuen wir uns auf Ihre vollständige Bewerbung.

gloor & lang ag life science careers
Frau Aline Fischer
Team Assistant
Bahnhofstrasse 31
5400 Baden
+41 61 206 61 81