Compliance Operations Lead, Associate Director
Location: Boston
Posted on: June 23, 2025
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Job Description:
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that all information I submit in my employment application is true
to the best of my knowledge. Job Description OBJECTIVES: Ensures
Global and R&D Quality processes are embedded and effectively
implemented across CPMQ Partner with teams across CPMQ to
proactively assess the needs for functional processes and system
enhancements Lead the development of internal functional processes
and training and ensure alignment with global processes and
regulatory requirements and expectations. Drive the implementation
and change management of processes and systems across CPMQ Create
mechanism to monitor the health of the QMS including the
identification of systematic quality compliance risks and
implementation of robust mitigation plans Engage with CPMQ teams to
foster a culture of learning and continuous improvement Lead CPMQ
continuous improvement initiatives to enable optimization of
clinical and safety quality compliance activities. Provide expert
advice and support to the CPMQ team on quality compliance
activities. Partner with Global Quality, R&D Quality teams and
contribute to enterprise-wide solutions. ACCOUNTABILITIES: Leads
and create simplified End to End functional processes and tools to
enable execution of CPMQ activities, ensuring alignment with global
processes and regulatory requirements. Create and deliver training
solutions to support the learning and implementation of functional
processes and systems Create and implement change management plans
for new and revised CPMQ processes and systems. Manage the CPMQ
training curriculum and ensure training is assigned to the
appropriate CPMQ team. Lead and embed the process for collating,
trending and interpretation of quality data for actionable insights
including the identification of systematic quality compliance risks
and implementation of robust mitigation plans Ensure maintenance of
the dashboards to monitor the health of the QMS and proactively
monitor and share across CPMQ the compliance metrics for CPMQ
activities e.g. audit, inspection, QE, CAPA. Organise Clinical and
Pharmacovigilance Quality council meetings and proactively manage
the agenda and ensure key priority topics and presentations are
captured and effectively communicated. Ensure that risks captured
on the CPMQ risk register are evaluated and escalated to the
Quality council and RDQ LT as applicable Drive the implementation
of the lessons learnt framework across CPMQ Provide expert guidance
to the CPMQ team on quality compliance activities. Provide guidance
and support to GCP, PV Health Authority inspections including
logistics. Present insights to the health of the QMS to CPMQ and to
our stakeholders. Represent CPMQ in Global Quality/R&D Quality
process and system improvement initiatives. Engage, share and embed
best practices into learning opportunities across CPMQ teams and
evaluate need for new/revised processes, tools and training
solutions. Act as Steward of the QMS within CPMQ (e.g. Quality
Events, Serious Breach, Change Control, Risk Register, Regulatory
Intelligence, Gap Assessment, Audits, Inspections, CAPA, SOP
management, training assignment etc) EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS: BSc in a scientific or allied
health/medical field (or equivalent degree). Minimum of 7 years of
increasing responsibility and relevant experience in the global
pharmaceutical industry in functions such as Clinical Operations,
Data Management and Statistics, with at least 3 years of experience
in GCP Quality/Compliance. Advanced knowledge of pharmaceutical
development, medical affairs and GCP/GVP regulations including FDA,
EU, MHRA, PMDA and ICH. Experience must include successful
development and implementation of a clinical or pharmacovigilance
audit program, hosting/leading regulatory inspections,
investigations and remediation activities on a global level.
Experience in managing complex organizational compliance issues and
in identifying and implementing organization-wide compliance
initiatives. Skilled in managing global, cross-functional projects.
Successful management of business transformation/change management
initiatives e.g. quality system integration, outsourcing strategy
etc Excellent communication skills to convey message. Exceptional
active listening skills to understand the needs and concerns of
others, which is crucial for finding win-win solutions. Outstanding
ability to apply critical thinking and problem-solving abilities to
address challenges and advocate for solutions. Demonstrated ability
to succinctly translate and effectively communicate the potential
impact of significant and complex issues. Fluency in written and
spoken English, additional language skills a plus. PHYSICAL
DEMANDS: Routine demands of an office-based environment TRAVEL
REQUIREMENTS: Willingness to travel to various meetings, including
overnight trips. Some international travel may be required. 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: Boston, MA U.S. Base Salary Range:
$153,600.00 - $241,340.00 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-termincentives. 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.
Locations Boston, MACHE - Glattpark (Opfikon) - Zurich HQ Worker
Type Employee Worker Sub-Type Regular Time Type Full 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.
Keywords: , Somerville , Compliance Operations Lead, Associate Director, Human Resources , Boston, Massachusetts
