Head, Clinical and Safety Quality Compliance (Hybrid)
Company: Takeda Pharmaceutical
Location: Boston
Posted on: April 25, 2024
Job Description:
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionJob Title: Head, Clinical and Safety
Quality ComplianceLocation: Cambridge, MA or Zurich,
SwitzerlandAbout the role:
- Leads the global Clinical, Pharmacovigilance, and Medical
Quality Compliance organization, providing quality oversight of the
quality systems supporting Takeda's clinical research (GCP),
pharmacovigilance (GVP) and medical activities across the
enterprise and ensuring that it's robust, aligned with and
compliant to applicable regulatory requirements, and governed and
-positioned for continual improvement.
- Establishes the quality oversight of Takeda's licensing
partners, and vendors and suppliers who are engaged to provide
regulated clinical research (GCP), pharmacovigilance (GVP) and
medical services. This includes a risk-based qualification and
audit program, quality agreements and governance.
- Serves as a senior strategic Quality Partner to various
Compliance functions in Data Science Institute (DSI), Global
Development Operations (GDO) and Global Regulatory Affairs
(GRA).
- Reports to the Head of CPMQ and is a key member of the CPMQ
Leadership Team, contributing to the design, implementation and
advancement of the CPMQ strategy, model and operations.How you will
contribute:
- Leads the CPMQ Compliance function in the development,
implementation and refinement of a proactive and risk-based quality
operating model for Takeda's clinical research (GCP),
pharmacovigilance (GVP) and medical activities across the
enterprise and -Takeda's licensing partners, vendors and
suppliers.
- Ensures a robust framework for the quality oversight, review
and approval of Quality Management System (QMS) standards and
procedures for regulated activities in Clinical Research (GCP),
Pharmacovigilance (GVP) and Medical. Actively participate in
quality system improvement initiatives and programs, championing
risk-based methodologies and compliance.
- Oversees and provides the strategy and framework for clinical
and pharmacovigilance inspections, ensuring readiness is embedded
in the processes, hosting and management of inspections are
adequately resourced by experts. Ensures that inspection risks and
findings are reported, escalated and adequately mitigated in a
timely manner.
- Executes foundational quality systems activities (e.g., change
control, deviations and investigations, incident notification and
escalation, CAPA, etc) for Clinical Research, Pharmacovigilance and
Medical are effective and appropriately resourced and
supported.
- Manages the Clinical & Safety Quality Council, communicating
any quality or compliance risks and opportunities and ensuring
relevant R&D management are well-informed to make decisions on
quality and compliance priorities. Contributes to other functional
Compliance meetings, as needed.
- Provides strategic direction in the development and monitoring
of relevant Key Quality Indicators (KQI) and metrics, data trending
and insights. Mitigates, communicates, and escalates any risks
flagged by the metrics and KQIs, ensuring actions are commensurate
to the risk and timely.
- In collaboration with Quality Compliance & Systems, provides
direction and subject matter expertise in the internal audit
program of the clinical research (GCP), pharmacovigilance (GVP) and
medical processes and systems across the enterprise.
- Sets the strategy, and leads the development and execution of a
risk-based audit program for the global business (licensing)
partners, vendors and suppliers.
- Ensures that the appropriate Quality Agreements are in place,
and that Takeda quality governance (e.g., Quality Management
Working Group, etc.) are conducted effectively and any critical
compliance risks are discussed, mitigated and reported with Takeda
management.
- Ensures robust talent development and succession planning
measures are in place to promote organizational growth/elevate
capabilities.
- Ensures there is a framework for knowledge management.
- Establishes avenues for Quality advocacy and governance.What
you bring to Takeda:
- Scientific or allied health/medical degree (BSc). Masters/PhD
preferred.
- Minimum of 15 years of increasing responsibility and relevant
experience in the global pharmaceutical industry, preferably with
at least 5 years of Quality/Compliance experience.
- Advanced knowledge of clinical research (GCP),
pharmacovigilance (GVP) and medical throughout R&D and
commercialization, and relevant regulations.
- Preferably with experience in strategic roles involving quality
systems and clinical portfolio oversight, large-scale audit
programs, regulatory inspection management, investigation and
remediation activities on a global level and successful management
of business transformation/change management initiatives e.g.,
quality system integration, outsourcing strategy, etc.
- Fluency in written and spoken English, additional language
skills a plus.Important ConsiderationsAt 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:
- Work in a controlled environment requiring special gowning and
wear protective clothing over the head, face, hands, feet and body.
This may include additional hearing protection for loud areas.
- 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-MA1Takeda 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, MAU.S. Base Salary
Range:$205,100.00 - $322,300.00The 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 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.LocationsBoston, MAZurich,
SwitzerlandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
time
Keywords: Takeda Pharmaceutical, Pawtucket , Head, Clinical and Safety Quality Compliance (Hybrid), Healthcare , Boston, Rhode Island
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