R&D Quality Associate Director: GCP Supplier Lead

Takeda; Łódź; On-site; PLN 350,000 - 482,000; Full time

Job summary

Takeda in Lodz, Poland, seeks an experienced QA leader to provide strategic quality oversight across the supplier and clinical network. You will ensure compliance, lead quality risk management, and drive CAPA and audit effectiveness in a global environment.

The role requires extensive GCP/GCLP/GVP expertise, with a track record of coordinating complex audits and collaborating across functions to uphold Takeda's quality standards.

Qualifications

• BSc in a scientific or allied health/medical field (or equivalent).
• Minimum of 10 years of increasing responsibility in global pharma, with at least 5 years in GCP/GCLP/GVP Quality/Compliance.
• Experience in managing complex cross-functional projects and leading quality initiatives.

Responsibilities

• Provides strategic quality oversight activities to strategic business partners and suppliers to promote quality compliance and risk management.
• Oversees the CSSQ audit program across clinical, safety and supplier domains with GCP/GCLP/GVP expertise.
• Reports to Head of Business Partner and Supplier Quality and supports development of CSSQ capabilities across the organization.
• Reviews audit results and escalates critical compliance risks to senior management.
• Leads as CSSQ SME for change controls, CAPA management, and audit report development.

Skills

Quality oversight

Quality management

Cross-functional leadership

GCP/GCLP/GVP knowledge

Audit program development

Communication skills

Education

BSc in a scientific or allied health/medical field

Job description

Takeda in Lodz, Poland, seeks an experienced QA leader to provide strategic quality oversight across the supplier and clinical network. You will ensure compliance, lead quality risk management, and drive CAPA and audit effectiveness in a global environment.

The role requires extensive GCP/GCLP/GVP expertise, with a track record of coordinating complex audits and collaborating across functions to uphold Takeda's quality standards.