Stability Team Lead (Hybrid)

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Job Title:Stability Management Lead - External Bio and ERT Products

Location: Lexington, MA - Hybrid Workplace position

About the role:

• Provide strategic oversight and leadership to the network pertaining to the stability program and strategy on External Bio and Enzyme Replacement Therapy Products

• Ensure compliance of Takeda’s stability programs with applicable regulations and guidelines

• Lead a team of highly skilled specialists (located in the US and EU) and provides guidance as well as opportunities for training and development of every team member

• Responsible for defending Takeda’s product stability program during inspections upon site request

How you will contribute:

• Managing the companies portfolio for External Bio and Enzyme Replacement Therapy Products, including correct and rapid execution of routine as well as for cause stability programs

• Regular review of related GMP regulations, guidelines, standards, and compendia to ensure Takeda’s processes are industry standard and in compliance

• Participate and vitally contribute to the global community of practice (CoP) for global stability

• Support of Takeda sites with any stability-related topics/questions/issues

• Drive improvement in the network, specifically overseeing integration activities and tailoring of stability processes to efficiently support the business

• Present global stability processes during inspections upon request of Takeda facilities

• Supporting Takeda sites during all phases of product development and implementation upon request

• Supporting departments working with CTLs (contract testing labs) and/or CMOs (contract manufacturing organizations) with regard to global stability-related topics

Key Accountabilities:

Leadership:

• Lead cross-functional teams of global experts/SMEs when defining Takedas’ strategy on global stability-related topics- or agency responses

• Exercise independent judgment to determine the most appropriate course of action including technique and method selection, protocol and study design and execution, in-depth data analysis, factor evaluation, and use of established practices and procedures for a variety of problems of broad scope and complexity, in alignment with organizational objectives

• The role is responsible to break down GMS/GQ global goals into specific goals for the stability management

Technical/Functional (Line) Expertise:

Provide global technical/quality support for various aspects of stability-related topics and on programs within the area of responsibility

Decision-making and Autonomy:

Exemplify and champion critical thinking in identifying and implementing highly innovative and effective solutions and strategies and leveraging established practices and procedures

​Interaction:

Frequently presents challenging issues and results at the department and cross-functional gatherings as well as project team meetings

​Innovation:

Work on abstract problems across functional areas of the business

Complexity:

The ability to define problems and draw conclusions or provide recommendations based on limited data as it relates to technical, regulatory/compliance, and operational issues.

What you bring to Takeda:

Essential Skills: Education, Experience, and Competencies Skills:

• A Master's degree with a minimum of 7+ years of relative industry experience

• A minimum of 3 years of experience in leading teams (preferably global teams)

• Experience in presenting during inspections

• Excellent communication, interpersonal and organizational skills

• Proactive at keeping current with literature, regulations, and latest technologies

• Ability to work well both independently and in a team environment

• Ability to prioritize own work and multitask, ability to prioritize the teams work

Desired Skills:

• Experience with stability-related processes preferred, hands-on experience in management, qualification, or manufacturing of pharmaceutical products

• Experience in managing quality systems

• Conducts work in compliance with cGMPs, safety, and regulatory requirements

• Experience in working with strategic initiatives and long-term planning

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This posting excludes Colorado applicants.

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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.