Associate Director, Clinical and Safety Quality Compliance Position Available In Suffolk, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge.

Job Description About the role:

TheAssociate Director, Clinical and Safety Quality Compliance isresponsible for ensuring the quality of processes and productoutputs. This role involves defining and specifying activities,processes, and standards to meet quality requirements, auditing andmonitoring processes, and ensuring compliance with corporate andregulatory standards. By maintaining high-quality standards, thisrole supports Takeda’s mission to provide better health and abrighter future.

How will you contribute:

Ensure compliance toRegulatory Intelligence Procedures by executing the regulatoryintelligence process in partnership with functional complianceteams for regulations impacting Clinical, Safety and ClinicalPharmacovigilance Medical Quality (CPMQ) processes and proceduresand determined by compliance to regulatory intelligence procedures.

Ensures a robust communication plan is in place (including briefdescription of the new and or revised regs, the impact, any risks,mitigation plans, timelines) that enables knowledge sharing ofregulatory intelligence insights and risks across CPMQ.Communicates to CPMQ periodically the progress of new and revisedregulations and impact. Ensure implementation of change control andactions completed to address new and revised regulations. Overseesthe review, completion and closure of routine and complex,impactful strategic clinical-related change controls and strategicPharmacovigilance-related change controls. Provides data insightsto emerging regulations and requirements, operational andcompliance metrics and storyboards, identifies quality andcompliance risks, and proactively provides strategic and tacticaldirections in the mitigation. Actively participate and contributeto enterprise-wide projects and initiatives, ensuring insightsrelated to clinical and safety quality are considered. Enable acompliant quality system in safety and clinical trial deliverysystems via CPMQ continual improvements projects. Activelyparticipate and represent in continual improvement projects,related to safety and clinical trial delivery in partnership with

GDO, PSPV, GRA

etc. Review the outputs of the safety and clinicaltrial delivery redesigned processes and coordinate CPMQ colleague’sinput. Provide CPMQ insights on continuous improvement that areenterprise-wide (ie Veeva, QMS, Enterprise Audit, etc.) to GlobalQuality and R D Quality. Present to CPMQ at periodic intervalsthe status, insights and impact of projects impacting clinical andsafety quality. Actively identifies key areas for processimprovements and develop and execute plans according to timelines.

Support the implementation of new and revised processes acrossCPMQ. Contributing to the design, implementation and advancement ofthe Clinical and Safety Quality Compliance strategy, model, andoperations as a key member of the Leadership Team. What you bringto

Takeda:

BSc in a scientific or allied health/medical field (orequivalent degree). Minimum of 7 years of increasing responsibilityand relevant experience in the global pharmaceutical industry infunctions such as Clinical Operations, Data Management andStatistics, with at least 3 years of experience in GCPQuality/Compliance. Advanced knowledge of pharmaceuticaldevelopment, medical affairs and GCP/GVP regulations including FDA,EU, MHRA, PMDA and ICH. Experience must include successfuldevelopment and implementation of a clinical or pharmacovigilanceaudit program, hosting/leading regulatory inspections,investigations and remediation activities on a global level.

Experience in managing complex organizational compliance issues andin identifying and implementing organization-wide complianceinitiatives. Skilled in managing global, cross-functional projects.

Successful management of business transformation/change managementinitiatives e.g. quality system integration, outsourcing strategyetc Excellent communication skills to convey message. Exceptionalactive listening skills to understand the needs and concerns ofothers, which is crucial for finding win-win solutions. Outstandingability to apply critical thinking and problem-solving abilities toaddress challenges and advocate for solutions. Demonstrated abilityto succinctly translate and effectively communicate the potentialimpact of significant and complex issues. Fluency in written andspoken English, additional language skills a plus.

GMSGQ ZR1

LI-MA1Takeda Compensation and Benefits Summary We understand compensationis an important factor as you consider the next step in yourcareer. We are committed to equitable pay for all employees, and westrive to be more transparent with our pay practices.

For Location:

Boston, MA U.S.

Base Salary Range:

$153,600.00 – $241,340.00 Theestimated salary range reflects an anticipated range for thisposition. The actual base salary offered may depend on a variety offactors, including the qualifications of the individual applicantfor the position, years of relevant experience, specific and uniqueskills, level of education attained, certifications or otherprofessional licenses held, and the location in which the applicantlives and/or from which they will be performing the job.

The actualbase salary offered will be in accordance with state or localminimum wage requirements for the job location. U.S. basedemployees may be eligible for short-term and/orlong-termincentives. U.S.based employees may be eligible toparticipate in medical, dental, vision insurance, a 401(k) plan andcompany match, short-term and long-term disability coverage, basiclife insurance, a tuition reimbursement program, paid volunteertime off, company holidays, and well-being benefits, among others.

U.S.based employees are also eligible to receive, per calendaryear, up to 80 hours of sick time, and new hires are eligible toaccrue up to 120 hours of paid vacation. EEO Statement Takeda isproud in its commitment to creating a diverse workforce andproviding equal employment opportunities to all employees andapplicants for employment without regard to race, color, religion,sex, sexual orientation, gender identity, gender expression,parental status, national origin, age, disability, citizenshipstatus, genetic information or characteristics, marital status,status as a Vietnam era veteran, special disabled veteran, or otherprotected veteran in accordance with applicable federal, state andlocal laws, and any other characteristic protected by law.

Locations Boston, MACHE – Glattpark (Opfikon) – Zurich HQ WorkerType Employee Worker Sub-Type Regular Time Type Full time JobExempt Yes It is unlawful in Massachusetts to require or administera lie detector test as a condition of employment or continuedemployment. An employer who violates this law shall be subject tocriminal penalties and civil liability.