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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

• Strong understanding of global Engineering and associated qualification/validation requirements

• Success working with multifunctional, cross-facility global teams

• Excellent interpersonal/communication (verbal and written)/influencing/negotiation skills required

• Must display personal accountability for results

• Strong relationship building skills, and ability to work in partnership cross functionally with global

stakeholders

• Business acumen with demonstrated ability to understand strategy and financial literacy

• Expertise of applicable good manufacturing practices, global regulations and guidances

• Experience with Health Authorities inspections and responses

• Ability to travel

• Fluent in English (read, write, speak)

Behaviors

• Finding innovative ways to serve patients, building trust, and reputation

• Creating the environment that inspires and enables people, maximizing their total involvement,

capabilities, growth, and potential

• Focus on the critical priorities and provide superior results

• Able to effectively build collaborative relationships with diverse functions at all levels of the

organization

• Passionate about innovating and driving for solutions including digital solutions

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing

change)

• Establishes a service oriented organization supporting enterprise activities in focus areas

• Interacts frequently with all levels of management including GQLT and other global functions and

business units

• Creates an environment that fosters lifelong learning and a growth mindset enabling employees to

thrive

• Promotes innovations, automation, and process consistency. Foster initiatives that would reduce

environmental impact

Establishes productive relationships and partners with relevant stakeholders across the

organization to ensure a clear, common understanding of objectives and achieve common goals

with shared accountability

Decision-making and Autonomy (The capacity and authority to make organizational decision-making, complexity of

decisions, impact of decisions, problem-solving)

• Demonstrated ability to make decisions, influence and manage conflicts/different opinions with

ability to drive solutions

• Understand and anticipate partners ́ needs and is an active and reliable team player

• Maintain focus and professionalism amongst frequently changing situations, circumstances and

priorities

• Consistently learn from new or difficult situations

Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external

relationships)

• Frequent contacts with equivalent level peers, cross functional partners and stakeholders

concerning global decisions within the focus areas, including projects, systems, processes and

strategy.

• Excellent communication, interpersonal and organizational skills

• Effectively leverage and continuously expand a network of internal and external relationships built

on trust and respect

• Lead by example in effective, open minded, and inclusive communication and collaboration

• Strong partnership with Quality Business Units Heads, R&D Quality, BioLife, DD&T, Regulatory

Affairs, Site Quality Heads, Site QC Heads, and other global Quality/ Functions to ensure strong

support and harmonization of Global Quality Governance/Oversight and Services on focus areas.

Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

• Advance technological knowledge, digitization, digitalization, and automation in focus areas with

the development and successful application of new concepts, approaches, practices and

standards in line with internal expectations and external benchmarks. Solutions can be applied

internally to this function or externally to the enterprise as a global solution.

• Encourages new ideas and innovative approaches from sites and partners

Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural consideration

Global scope: impact across all Takeda including R&D, BioLife, GMS/GQ, DD&T, External lab

partners

• Work on complex problems in which analysis of situations or data requires an in depth evaluation

of various factors. Exercises judgement within broadly defined practices and policies in selecting

methods, techniques and evaluation criteria for obtaining results. Able to identify solutions to

complex issues of operational, compliance or regulatory nature

• Ability to embrace and drive focused changes across the organization and across different

cultures

• Find creative and effective ways to ensure achievement of desired outcomes despite difficulties.

• Understand and use systematic approaches to risk assessment and management

• Ensure budget, schedules, and performance requirements are met. Expected to escalate issues

as appropriate in a timely fashion

ADDITIONAL INFORMATION (Add any information legally required for your country here)

\#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

$174,500.00 - $274,230.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._

Locations

Lexington, MACHE - Glattpark (Opfikon) - Zurich HQ

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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