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gloor&lang AG
Global GMP Quality System Manager- (Contractor)gloor&lang AG • Basel, Basel-Stadt, Switzerland
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Global GMP Quality System Manager- (Contractor)

Global GMP Quality System Manager- (Contractor)

gloor&lang AG • Basel, Basel-Stadt, Switzerland
Vor 3 Tagen
Stellenbeschreibung

Global QMS Governance GMP Compliance Continuous Improvement6-Months

We are seeking an experienced Global Senior GMP Quality Systems Manager for a six-month contractor assignment within an international biopharmaceutical environment. The role will focus on strengthening and continuously improving a global Quality Management System.

Key Responsibilities

  • Develop implement and maintain an agile compliant global GMP Quality Management System.
  • Lead the harmonisation and continuous improvement of quality processes across manufacturing and supply-chain operations.
  • Monitor GMP performance indicators identify trends and drive corrective and preventive improvements.
  • Support global inspection readiness and provide GMP expertise during audits and regulatory inspections.
  • Assess new and changing regulations and translate them into effective processes and procedures.
  • Develop and maintain GMP training programmes.
  • Support and enhance electronic Quality Management Systems (eQMS).
  • Collaborate with global Quality Operations Regulatory Affairs Supply Chain Validation IT and external manufacturing partners.
  • Promote a strong quality culture across an international cross-functional organisation.

Your Profile

  • Bachelors degree in Life Sciences Pharmacy Regulatory Affairs or a related field.
  • At least five years of experience in the pharmaceutical or biotechnology industry particularly within GMP quality systems or manufacturing.
  • Strong knowledge of international GMP requirements including FDA EMA ICH and PIC/S standards.
  • Proven experience in quality-system design implementation governance and compliance.
  • Experience with eQMS platforms quality metrics KPIs and Quality Management Reviews.
  • Strong project-management problem-solving and root-cause-analysis skills.
  • Excellent communication and facilitation skills with the ability to influence multicultural teams in a matrix organisation.
  • Proactive pragmatic and solution-oriented working style
  • Fluent English.

This is an opportunity to take on a highly visible global assignment and make a meaningful contribution to regulatory compliance operational excellence and continuous quality improvement.


Employment Type : Freelance
Experience: years
Vacancy: 1

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Global GMP Quality System Manager- (Contractor) • Basel, Basel-Stadt, Switzerland