Job Posting

Director, GCP Process Excellence

Remote

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Job Level: Senior
Travel: Minimal

At Takeda, we exist to create better health for people and a brighter future for the world. While we continually evolve science and technology, our ambition remains steadfast — we move science forward so we can transform more lives. The Global Development Organization (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.

Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development. We’re building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety. GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.

At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials. It is our passion for people that transforms our work into meaningful action. Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.

Job ID R0147555 Date posted 03/20/2025 Location Remote

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Job Description

OBJECTIVES/PURPOSE:

Global Development Compliance ensures quality and regulatory adherence across clinical development by collaborating with R&D Quality and R&D Good Clinical Practice (GCP) functions. By advocating for the adoption of our Future Fit Ways of Working, we endeavor to drive continuous improvement, stimulate innovation, and establish an efficient, inspection-ready clinical trial delivery operating model. Recognizing technology and automation as essential priorities, we aim to leverage digital tools to enhance efficiency, streamline processes, and accelerate the delivery of our drug pipeline, thereby bringing medicines to patients more swiftly.

The Director of GCP Process Excellence is tasked with overseeing compliance with the global leadership and strategic direction for the Quality Management System (QMS) and the Standard Operating Procedure (SOP) development and maintenance strategy for clinical trial delivery, in coordination with R&D Quality Assurance (QA). The Director will employ innovative methodologies and foster new ideas from subject matter experts to optimize clinical trial delivery process efficiency, taking into account the interplay of people, processes, and technology. This role will execute on the strategy for end-to-end process development and continuous improvement framework. This will include collaborating with Functional Leaders, Business Process Owners (BPOs), and departments like R&D Quality, Ethics, and Compliance, to define, develop, and operationalize SOPs, support implementation, and ensure regulatory compliance.

ACCOUNTABILITIES:

Partner with other Global Development Compliance functions, R&D QA, BPOs and functional leadership to ensure delivery of the end-to-end processes for incorporating Future Fit ways of working to enable the clinical trial delivery operating model (analyze, design, develop, implementation, adoption, change management etc.).
Execution of the QMS SOP framework for clinical trial delivery, ensuring ongoing engagement of R&D QA, BPOs, stakeholders (internal and external) and functional leadership
Work with R&D QA, functional leaders, BPOs and stakeholders (internal and external) to confirm business impact is well-understood and accountabilities are clearly defined
Enable capabilities to maximize clinical trial delivery process definition and development efficiency, looking for opportunities for continuous improvement in our ways of working
Facilitate the Business Process Owner (BPO) and Business System Owner (BSO) Network to ensure consistency and effective connections between business process and system process in clinical trial delivery
Partner with GCP Functions to drive optimization activities and initiatives to ensure proper support (change management, training, adoption) is applied for successful implementation
Provide support on QA QMS Initiatives
Ensure process changes are incorporated as required by regulation or CAPAs
Provide support for inspections and internal audits

CORE ELEMENTS RELATED TO THIS ROLE:

Experience with the pharmaceutical Industry, including research and development and clinical trials conduct
Strong understanding of business process development and documentation best practices
Visibly engage across the organization to ensure transformational impact
Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
Provide input to highly complex decisions that impact overall R&D
Ability to seek diverse input from multiple stakeholders to drive innovative solutions
Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business
Enables strategies for effecting change, controlling change, and helping people to adapt to change
Proactively identifies and communicates issues before they arise and develops contingency plans
Ability to work in a global organization with a high degree of complexity and understand broader, enterprise level perspective
Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization, creating a culture that fosters innovation

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

BS, MS or equivalent
Minimum of 10+ years experience in pharmaceutical, CRO, healthcare or related industry
Minimum of 5+ years experience with QMS and process development for clinical trial delivery
Deep knowledge and/or experience within clinical trial delivery operations and clinical trial lifecycle
Solid understanding of US CFR, GCP, ICH regulations and the clinical development process
Experience in problem solving, negotiations and collaborative team building with peers and other stakeholders is required
Demonstrated ability to positively influence outcomes, key project decisions, and strategic problem-solving
Proven ability to communicate clearly and present key information objectively to all levels of the organization including executive management
Experience in stakeholder relationship management; Influential in orchestrating key stakeholders and project teams to turn vision into reality
Experience with matrix organization, business projects, multi-disciplinary teams or strategic change management projects
Excellent oral and written communication skills, business acumen, and enterprise knowledge
Understand design thinking and can explain and convince stakeholders
Work with virtual teams in different locations, aligning and adapting different work, culture, and communication styles
Function well under pressure in a changing environment

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:

Massachusetts - Virtual

U.S. Base Salary Range:

$169,400.00 - $266,200.00

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.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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Where you fit in

As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients. You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.

We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs. But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.

Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.

Advance clinical research
Deliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity
Enable end-to-end management of clinical supply
Ensure safety management and inspection readiness

One of the main reasons I came to Takeda is because of the people I would be working for.We all use PTRB as our North Star. I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.

Marisa Rackley - Head, Clinical Site Startup & Engagement, Global Development Office

It’s leveraging technology, it’s leveraging data in a very different way. It’s not just about using the data that we generate, but using real world data and having access to a much more holistic set of data in order to drive the way we work and deliver medicines to patients.

Penny Carlson - Head, Global Clinical Development Operations

The heart of our work

Shining a light on new perspectives

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Integrity
Fairness
Honesty
Perseverance

Working at Takeda

Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.