Senior Compliance Specialist
7 days ago
This role is critical in ensuring compliance with regulatory standards and maintaining a high level of quality across the organization.
Key Responsibilities:- Manage third-party and regulatory inspections, including audits and self-inspections.
- Lead internal audits and maintain quality agreements with internal and external partners.
- Drive quality risk management and change control processes to ensure continuous improvement.
- Analyze and report on site KPIs, APQRs, and global quality metrics.
- Support the implementation and maintenance of the Quality Management System.
- Minimum 3 years' experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
- Strong knowledge of global regulatory standards and QMS.
- Experience managing audits and compliance programs.
- Ability to critically analyze data and provide quality insights.
- Strong stakeholder engagement, written and verbal communication skills.
- Degree in Science, Pharmacy, Engineering, or related discipline.
Culture: You will be part of a collaborative quality team that values excellence, innovation, and continuous improvement.
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