Head Global Quality Equipment and Facilities Validation Compliance

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Job Description

OBJECTIVES/PURPOSE

• 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 at Takeda to
ensure compliance with GxP regulatory and quality standards while maintaining the integrity of
data
• 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 applicable North Star systems to capture engineering and
associated validation activities, such as installation and operational qualifications (IQ/OQ),
Process qualifications (PQ) and leads the 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.
• Collaborates with Global Sterility Control functions to ensure up to date adherence to global
aseptic processing requirements

How you’ll make an impact/contribute:

• 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 appropriate mechanisms including KPI’s to identify trends, patterns, and
opportunities in order to take proactive measures to continuously improve across the GxP
enterprise and sustain compliance excellence.
• Business Process Quality owner for Associated Engineering and Commissioning/Qualification
documents.
• Establishes and/or supports Communities of Practice to ensure/help enterprise-wide
engineering and associated process understanding and compliance
• Provide input to GQ Compliance to help shape priorities.
 

EDUCATION, BEHAVIOURAL COMPETENCIES, AND SKILLS:

Technical/Functional (Line) Expertise (Breadth and depth of knowledge, application and complexity of technical
knowledge)
• Bachelor ́s degree in a relevant scientific /technical field. Advance degree a plus (i.e. BSc, MSc,
PhD in Chemistry, Biochemistry, Pharmacy or Engineering (e.g. Chemical Engineering,
Bioprocessing).
• Minimum of fifteen (15) years of experience in the Life sciences industries (pharma/bio/devices)

Strong leadership skills and demonstrated success in managing as an individual contributor
through various functions
• Strong analytical, critical thinking and problem solving skills
• Stron