Takeda Pharmaceuticals
Compliance Operations Lead, Associate Director
Takeda Pharmaceuticals, Boston, Massachusetts, us, 02298
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that
the information I provide in my application will be processed in line with
Takeda’s
Privacy Notice
and
Terms of Use .
I further attest 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 CPMQPartner with teams across CPMQ to proactively assess the needs for functional processes and system enhancementsLead 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 CPMQCreate mechanism to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plansEngage with CPMQ teams to foster a culture of learning and continuous improvementLead 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 systemsCreate 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 plansEnsure 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 applicableDrive the implementation of the lessons learnt framework across CPMQProvide 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 etcExcellent 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 environmentTRAVEL REQUIREMENTS:Willingness to travel to various meetings, including overnight trips. Some international travel may be required.Takeda Compensation and Benefits SummaryWe 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:149,100.00 - 234,300.00
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
e
mployee
s
may be eligible for
s
hort
-
t
erm and/
or
l
ong-
t
erm
incentive
s
.
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 StatementTakeda 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, MAZurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job ExemptYes#J-18808-Ljbffr
the information I provide in my application will be processed in line with
Takeda’s
Privacy Notice
and
Terms of Use .
I further attest 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 CPMQPartner with teams across CPMQ to proactively assess the needs for functional processes and system enhancementsLead 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 CPMQCreate mechanism to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plansEngage with CPMQ teams to foster a culture of learning and continuous improvementLead 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 systemsCreate 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 plansEnsure 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 applicableDrive the implementation of the lessons learnt framework across CPMQProvide 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 etcExcellent 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 environmentTRAVEL REQUIREMENTS:Willingness to travel to various meetings, including overnight trips. Some international travel may be required.Takeda Compensation and Benefits SummaryWe 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:149,100.00 - 234,300.00
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
e
mployee
s
may be eligible for
s
hort
-
t
erm and/
or
l
ong-
t
erm
incentive
s
.
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 StatementTakeda 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, MAZurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job ExemptYes#J-18808-Ljbffr