Head of Quality Compliance and Systems

1 week ago

Singapore Takeda Full time

Overview Head of Quality Compliance & Systems (QC&S) role at Takeda – Woodlands, Singapore. Responsibilities Lead the QC&S Department, ensuring compliance with Takeda Quality Management System (QMS) and site regulations. Lead gap analysis and implement QMS procedures across all departments. Serve as QMS system SME, managing regulatory inspections. Ensure quality council meetings run smoothly with accurate minutes and action tracking. Guide annual Product Quality Reviews and periodic trend reviews. Review regulatory and customer responses, ensuring timeliness and accuracy. Manage Product Complaint Management and coordinate escalations for holds, BPDR, field corrective actions, and notifications. Collaborate with Incident Management to assure timely escalation and resolution. Oversee validation activities, change review board and change control QMS. Drive continuous improvement projects for quality, efficiency, and cost. Implement QRM, Data Integrity, Supplier Quality Management, and reinforce quality compliance culture. Lead key departmental and site projects. Manage QC&S budget, forecasting, and resource planning. Align operations with GQ/GMS/DD&T digital initiatives. Adhere to GMP, cGMP, company policies, leadership behaviors, and performance management. Champion continuous improvement and Takeda-ism values. Resolve quality issues, gaps, and ensure regulatory compliance. Set direction for the QC&S team, shaping relevant policies and influencing organizational goals. Leadership Develop and inspire the QC&S team. Define strategies, priorities, and compliance standards. Collaborate with quality counterparts across Takeda sites. Coach and develop team members. Plan talent development and succession. Build relationships with global stakeholders and cross-functional departments. Represent Site Quality Head as needed. Other Responsibilities Adhere to relevant EHS requirements. Commit to fair and respectful behavior per Takeda Code of Conduct. Perform any duties assigned by supervisor. Qualifications Education and Experience Requirements. Degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, engineering, or related discipline. Auditor training or QP training advantageous. 10 years experience, 5 years supervisory position in pharmaceutical or biotechnology quality functions, GMP compliance, operations, or validation. Knowledge of FDA 21CFR, EU Eudralex, ICH Guidelines, PIC/S GMP Guide, EU GMP Annex 1, etc. Understanding of biologics manufacturing processes, laboratory operations, clean utilities, and product disposition. Key Skills and Competencies Strong leadership and communication across the organization. Recognized success in influencing stakeholders. Proven collaboration cross-functionally and across sites. Experience with FDA, EMA, HSA or equivalent inspections. Led inspection readiness programs. Diplomatic communication with diverse personalities. About Takeda Takeda transforms patient care through novel specialty pharmaceuticals and patient support programs. A patient-focused company that fosters an inclusive, collaborative workplace dedicated to delivering better health. Location Woodlands, Singapore. #J-18808-Ljbffr

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