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Job Description

OBJECTIVES/PURPOSE

The Principal Manager in PSDQ Systems will perform the following high-level objectives:

Leads the day-to-day execution of a variety of process that ensure the continued compliance of the PSDQ organization, typically involving data, metrics and KPIs, including predictive data analytics.Provides systems support to members of PSDQ, and its key business partners, ensuring adherence to existing SOPs and sharing expertise as available.Key contributor in the rollout and implementation of new processes across PSDQ, and its key business partners to, providing clear, transparent, and consistent support.Defines, plans, and executes projects for the continuous improvement of PSDQ processes, ensuring a compliant and efficient approach to its systems and continued process excellence.

ACCOUNTABILITIES

Independently gather, collate, and distribute metrics associated with the performance of the Quality Management System, Supplier Quality, or others as applicable, including through predictive data analysis.  Assist in the gathering and execution of information for Quality Council and may present this information in applicable Quality Councils.Leads PSDQ’s Quality Risk Management program, activities and documentation, both for medical device products and pharmaceutical development.  Serves as a key point of contact for risk owners within PSDQ, and Pharmaceutical Science that need guidance on the performance of Risk Management activities.Through close collaboration with Pharmaceutical Science and Regulatory CMC and partnering with the Head of Quality Systems & Data Analytics, support the establishment of a blueprint for the transformation of science performed within these organizations from bench to in silico first, ensuring quality requirements are clearly outlined and phase appropriate.Serve as an SME for PSDQ on the implementation of digital tools and the visualization of data, driving efficiency and automation of content.Lead day-to-day operation of the Document and/or Learning Management Systems, including managing workflows, assigning curricula, and capturing metadata.  May serve as training coordinator for others in the organization.  Act as point of contact for others with DMS / LMS questions.Execute central tasks associated with the continued operation of PSDQ from an administrative perspective and serve as system owner for some centrally accessed QMS systems.Define and lead critical projects which enhance PSDQ’s efficiencies and innovation.  Engage cross-functionally on behalf of PSDQ to serve key business partners.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

Working knowledge of current Good Manufacturing Practice requirements for the biopharmaceutical and medical device industriesExperience in compliance and systems related processes and tasksExperience with risk management strategies and general project managementProven success in identifying and implementing continuous improvement initiativesProficient in analyzing data to identify performance trendsAbility 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 skillsClear, concise, and consistent in written and verbal communicationsHigh attention to detail

Decision-making and Autonomy

Able to manage projects, initiatives and tasks with oversight.  Able to analyze data and make recommendations to management and/or escalate as appropriate.

Interaction

Experience working within complex/matrixed and global organizationsDemonstrated 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 documentsEffectively 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 risksAbility to anticipate potential problems and risks related to quality expectations and regulatory compliance, formulate action plans, and implement solutionsAbility to work effectively in a fast paced, rapidly changing environment and to work on multiple work streams and projects simultaneously

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Bachelor’s Degree in Chemistry, Biology, Engineering, or related field.Minimum of 5 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 3 years in GMP Quality or Compliance.Six sigma/lean processing, project management professional and/or auditor certification preferred.

#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:

Lexington, MA

U.S. Base Salary Range:

$108,500.00 - $170,500.00

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-term incentives. 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.

LocationsLexington, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull 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.