Global GMP Quality System Manager- (Contractor)
On-siteBasel, Basel-City, Switzerland
Job Summary
Develop and maintain an agile, compliant global GMP Quality Management System while leading harmonization and continuous improvement across manufacturing and supply-chain operations. Monitor GMP performance indicators to drive corrective and preventive actions, support global inspection readiness during audits, and translate new regulations into effective processes. Develop GMP training programs, enhance electronic Quality Management Systems, and collaborate with global Quality, Operations, Regulatory Affairs, Supply Chain, Validation, IT, and external partners to promote a strong quality culture. This six-month contractor assignment focuses on strengthening governance within an international biopharmaceutical environment.
Required Qualifications
- 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
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