Global GMP Quality System Manager-

gloor & lang ag; Basel; Vor Ort; CHF 130.000 - 195.000; Teilzeit

Zusammenfassung

gloor & lang ag in Basel is seeking an experienced Global Senior GMP Quality Systems Manager for a six-month contractor assignment in an international biopharmaceutical setting. You will strengthen and continuously improve a global Quality Management System.

You will lead harmonisation of quality processes, monitor GMP metrics, support audits, and translate evolving regulations into practical procedures, enabling regulatory compliance and operational excellence.

Qualifikationen

• Bachelor's degree in Life Sciences, Pharmacy or Regulatory Affairs.
• At least five years in pharma/biotech with GMP quality systems or manufacturing.
• Strong knowledge of FDA, EMA, ICH and PIC/S GMP standards.
• Experience designing, governing and improving quality systems and eQMS.
• Excellent communication and cross-functional collaboration skills.
• Fluent English.

Aufgaben

• Develop, implement and maintain a global GMP Quality Management System.
• Lead harmonisation and continuous improvement of quality processes across manufacturing and supply chain.
• Monitor GMP performance indicators, identify trends and drive CAPA.
• Support inspection readiness and provide GMP expertise during audits.
• Translate changing regulations 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, Supply Chain, Validation, IT and external partners.
• Promote a strong quality culture across an international organisation.

Kenntnisse

Project management

Problem solving

Root-cause analysis

Communication

Facilitation

Cross-cultural collaboration

Quality systems

Ausbildung

Bachelor's degree in Life Sciences / Pharmacy / Regulatory Affairs

Tools

eQMS

Jobbeschreibung

Global QMS Governance | GMP Compliance | Continuous Improvement|6-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

• Bachelor’s 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.