Head Global Quality Equipment and Facilities Validation Compliance

Role Summary

Head Global Quality Equipment and Facilities Validation Compliance. Provides governance and oversight to all GxP Engineering and associated Equipment validation activities, ensuring compliance with GxP regulatory and quality standards while maintaining data integrity. Partners with cross-functional teams to establish and sustain GxP validation practices across Takeda.

Responsibilities

• Provides governance and oversight to all GxP Engineering and associated Equipment validation activities, including Facility Engineering standards, Maintenance and Calibration processes, Commissioning, Installation, Operational, and Process Qualifications to ensure compliance with GxP regulatory and quality standards.
• Oversees business processes and partners with Business Process Owners for applicable validation activities to ensure consistency of approach across the network, including validation site master plans.
• Ensures consistent use of North Star systems to capture engineering and associated validation activities (IQ/OQ, PQ) and leads teams that conduct oversight for GxP systems such as evaluation and approval of all GxP classification evaluation and system validation activities.
• Collaborates with Global Engineering, PharmSci, and MSci functions to ensure pragmatic and compliant validation approaches for engineering design, qualifications, and changes and tech transfers (internal/external or both).
• Collaborates with various functions across Takeda to develop a structure for GxP compliance, sustainability, and improvement activities related to engineering and qualifications.
• Provides expert support for regulatory inspections and responses to Health authorities regarding areas under this function, and collaborates with Global Sterility Control functions to ensure up-to-date adherence to global aseptic processing requirements.
• Establishes practices for GxP Engineering and associated commissioning, qualification, and validation processes and executions that enhance decision-making and regulatory compliance by assuring execution consistency and accuracy.
• Establishes mechanisms including KPIs to identify trends and opportunities to continuously improve across the GxP enterprise and sustain compliance excellence.
• Serves as Business Process Quality owner for Associated Engineering and Commissioning/Qualification documents and supports Communities of Practice to ensure enterprise-wide engineering process understanding and compliance.
• Provides input to GQ Compliance to help shape priorities.

Qualifications

• Minimum of fifteen (15) years of experience in the Life sciences industries (pharma/bio/devices).
• Bachelor‚Äôs degree in a relevant scientific/technical field; advanced degree (MSc/PhD) in Chemistry, Biochemistry, Pharmacy, or Engineering is a plus.
• Strong leadership skills and demonstrated success in managing as an individual contributor across functions.
• Strong analytical, critical thinking, and problem-solving skills; good understanding of global Engineering and qualification/validation requirements.
• Experience working with multifunctional, cross-facility global teams; excellent interpersonal/communication (verbal and written) and influencing/negotiation skills.
• Personal accountability for results; strong relationship-building skills; ability to work cross-functionally with global stakeholders.
• Business acumen with demonstrated ability to understand strategy and financial literacy; knowledge of GMPs, global regulations, and guidances.
• Experience with Health Authority inspections and responses; ability to travel; fluent in English (read, write, speak).

Skills

• Leadership and people management; strategic thinking and decision-making; project management.
• Strong communication, collaboration, and networking skills across global teams.
• Digital solutions awareness and interest in innovation and automation for process improvements.
• Risk assessment and management; ability to drive focused changes across organizations and cultures.

Education

• Bachelor‚Äôs degree in a relevant scientific/technical field. Advance degree a plus (MSc, PhD).

Additional Requirements

• Ability to travel.