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Job Description

Job Title: R&D Quality Services Improvement Leader

Location: Cambridge, MA

About the role:

Provides leadership and oversight of the quality services improvement supporting Takeda’s R&D Quality organization across the RDQ enterprise, interacting with RDQCS leadership and representatives from R&D Quality functional areas.  Ensures RDQCS business and compliance processes are robust, aligned with, and compliant to applicable regulatory requirements, governed and positioned for continual improvement.

• Designs Quality Strategies to drive improvement, innovation, and predictive quality measures, in partnership with RDQCS LT.

• Demonstrates leadership in the RDQCS organization to promote strategic thinking and innovative approaches, driving Change Management to facilitate transformation, integration, and improvement initiatives across the organization.

• Oversees budget and resource management for the RDQCS, partnering with Head of RDQCS, RDQCS LT, Finance and others as needed.

• Interprets RDQCS metrics to identify and communicate compliance risks and liaise with appropriate R&D/R&D Quality functions to drive organizational process improvements.

How you will contribute:

• Leads the development of the RDQCS strategic development in alignment with the GQ and RDQ Strategies, including long- and mid-range plans aligned to growth/pipeline development, network strategy and business imperatives by providing input to key strategic, pipeline, and financial decisions.

• Monitors progress toward RDQCS goals and works across the organization to develop KPI reports and metrics.  Intervenes and escalates, as necessary, to ensure that RDQCS is on track to meet or exceed performance targets.  Provides complex analysis and insight in evaluating overall organizational performance over time and for future planning.

• Serves as a strategic thought partner to the Head of RDQCS and the RDQCS leadership team with regards to complex problems, current and future initiatives, strategies, and budget.  Looks across R&D Quality to identify efficiencies and interdependencies to ensure optimal working models.

• Builds and maintains a communication strategy, plan and platform for RDQCS.  Partners across RDQ to ensure efficient, effective communication and decision making.

• Provides professional expertise and strong leadership in RDQCS guidance and regulations.

• Defines, leads, and implements critical projects which enhance RDQ’s efficiencies and innovation.  Engage cross-functionally on behalf of RDQ to serve key business partners.

What you bring to Takeda:

• Minimum of 6 years professional working experience in the field of healthcare products or related activities such as pharmaceutical or device manufacturing, Quality Control or Quality Assurance including at least 4 years in GXP Quality or Compliance.

• Bachelor’s Degree in Chemistry, Biology, Engineering, or related field preferred.

• Six sigma/lean processing, project management professional and/or auditor certification preferred

Technical/Functional (Line) Expertise

• Working knowledge of current GxP (e.g.,, Good Manufacturing Practice, Good Laboratory Practices, Good Clinical Practices, Pharmacovigilance) requirements for the pharmaceutical industry

• Experience in compliance and systems related processes and tasks

• Experience with risk management strategies and general project management

• Proven success in identifying and implementing continuous improvement initiatives

• Proficient in analyzing data to identify performance trends

• Ability to proactively manage the development and re-engineering of key processes and systems in support of the business’s mission

Leadership

• Demonstrated teamwork, initiative, and problem-solving skills

• Clear, concise, and consistent in written and verbal communications

• High attention to detail

Decision-making and Autonomy

• Able to manage projects, programs and tasks with little, to no, oversight.  Able to analyze data and make recommendations to management and/or escalate as appropriate.

Interaction

• Experience working within complex/matrixed organizations

• Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization

Innovation

• Ability to read, analyze and interpret common scientific and technical data/reports and legal/regulatory documents

• Effectively presents information to management, internal groups, and stakeholders

Complexity

• Analytical capabilities with the ability to analyze a wide variety of information and data to determine potential risks

• Ability to anticipate potential problems and risks related to quality expectations and regulatory compliance, formulate action plans, and implement solutions

• Ability to work effectively in a fast paced, rapidly changing environment and to work on multiple work streams and projects simultaneously

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

#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:

U.S. Base Salary Range:

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.

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Job Exempt