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Associate Director, GCP Compliance

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 Office (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 R0138690 Date posted 11/13/2024 Location Remote

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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, GCP Compliance based remotely reporting to the Director, GCP Compliance.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

  • Direct and drive the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and tools
  • Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related compliance assessments
  • Develop and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery

ACCOUNTABILITIES:

Compliance Management

  • Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting
  • Facilitate clinical trial delivery internal audits with study teams and functional areas including but not limited to: study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation. Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.
  • Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategies

Compliance Assessments

  • Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance
  • Advise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects to address risks and issues
  • Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to the plan

GCP Compliance Metrics and Reporting

  • Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities
  • Identify, develop, and track KPIs, metrics and dashboards to track process quality and compliance

Other

  • Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers
  • Act as role model for Takeda’s values

EDUCATION AND EXPERIENCE:

  • Bachelor’s Degree or international equivalent required; Life Sciences preferred.
  • 8 or more years' experience in the pharmaceutical industry and/or clinical research organization, including 6 or more years in compliance or clinical study management required.
  • Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
  • Experience in leading projects and coordinating collaboration with cross-functional teams.
  • Strong strategic thinking, planning, execution, and communication skills.
  • Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development.
  • Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

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:

149,100.00 - 234,300.00

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

#LI-Remote

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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

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

Penny Carlson - Head of Innovation and Data, Global Development Office

The culture at Takeda is very unique. It’s a culture that’s extremely collaborative in nature, requiring people from diverse backgrounds to come together, speak up, and really think about the most important thing we need to do for our patients.
Saurabh Awasthi

Saurabh Awasthi - Executive Director, Trial Insights & Performance Optimization, Global Development Office

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.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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