Global GMP Quality System Manager- (Contractor)
gloor&lang AG Basel Freiberuflich/Selbständig
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.
- 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.
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