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Job Description

Job Title: Head RDQCS Compliance

Location: Cambridge, MA

About the role:

Leads the global R&D Quality Compliance organization, providing oversight of the quality systems supporting Takeda’s R&D Quality organization across the RDQ enterprise and ensuring that it is robust, aligned with, and compliant to applicable regulatory requirements, and governed and positioned for continual improvement.

• Establishes the framework for quality oversight of the R&D Quality Management System.

• Serves as a strategic Quality Partner to Compliance leads across R&D Quality and the Enterprise Global Quality organization.

• Key member of the RDQCS Leadership Team, contributing to the design, implementation and advancement of the R&D Quality Management System strategy, model and operations.

How you will contribute:

• Responsible for the RDQ framework of audit and inspection management, inspection readiness, gap assessments, risk management and incident escalation.  Builds strategic plans for R&D audit programs and inspection preparation to minimize critical observations and ensure Takeda’s regulatory reputation remains positive with global authorities in coordination with R&D Quality leadership.

• Leads the systematic application of Risk Management principles across RDQ, ensuring consistency of approach and compliance to SOPs.  Responsible for authoring, editing, and circulating for approval the associated family of documents.

• Owner of the RDQ Regulatory Intelligence program, reviewing, documenting and gap assessing global regulatory changes across all GxPs (GMP, GCP, GDP, GLP, PV) used within R&D/R&D Quality to ensure continued compliance with current global regulations.

• Accountable for strategic oversight of the application of the gap assessment process, ensuring consistency of approach and compliance to SOPs.  Responsible for identifying and executing on process improvements that are identified associated with the process.

• Leads the R&D Quality Compliance team in stewardship of the R&D Quality Management System, ensuring R&D and R&D Quality remain in compliance with Global GxP regulations.  

• Leads representatives from across R&D/R&D Quality those who serve as system owners for centrally accessed QMS processes Advances R&D/RDQ-wide forums to increase awareness, foster cross-functional learning, and improve knowledge.  Works with system owners to develop metrics, trending programs, and continuous improvement plans for processes and systems used across R&D/R&D Quality.

• Define, lead, and implement critical projects which enhance RDQ’s efficiencies and innovation.  Engage in global, enterprise-wide cross-functional project and programs on behalf of RDQ to serve key business partners in R&D/R&D Quality.

• Provides subject matter expertise and consultation for R&D Compliance related to deviations, CAPAs, change controls, responses to inspection outcomes and incident escalations.  Escalates issues and incidents with regulatory authorities in coordination with  R&D and R&D Quality leadership.

What you bring to Takeda:

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

• Minimum of 10 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 GMP Quality or Compliance.

• 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. 

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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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