Head of Pharmaceutical Sciences and Device Quality (Hybrid)
Posted on: February 12, 2024
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Job Title: Head of Pharmaceutical Sciences and Device Quality
Location: Lexington, MA
About the role:
- Leads the global Pharmaceutical Sciences and Device Quality
function, providing quality oversight of R&D Pharmaceutical
Sciences, and ensuring compliance with regulatory requirements and
Takeda expectations for the investigational medicinal products and
devices across the enterprise.
- This position is directly responsible for developing and
aligning strategies that ensure products utilized in Takeda
clinical studies are produced in compliance with applicable
regulations and Takeda quality expectations and are dispositioned
in a timely manner to meet clinical study and developmental
- Serves as a senior strategic Clinical Good Manufacturing
Practice and Device resource to Takeda. Subject matter expert role
for the preparation, conduct, response, and follow-up to health
authority inspections of Takeda's R&D activities.
How you will contribute:
- Leads the Pharmaceutical Sciences and Device Quality function
in the development, implementation, and refinement of processes to
ensure that Takeda maintains oversight of the quality of its
clinical trial materials and enterprise-wide devices in compliance
with applicable regulatory requirements.
- Serves in a consultative role for compliance-related matters
and supports R&D in implementing corrective and preventive
actions (CAPAs). Develops strategic, pragmatic initiatives to
- Sets the strategy and leads the development and execution of
the master audit schedule for Contract Manufacturing Organizations
(CMOs), working collaboratively with stakeholders to ensure that
the audit program is robust. Ensures that appropriate CAPAs are
implemented in a timely manner. Identifies potential systemic gaps
and coordinates with the appropriate stakeholders to ensure a
timely resolution. Escalates issues of potentially critical
non-compliance and/or lack of urgency in remediation to senior
management. Analyzes results to identify actionable trends and to
promote a state of compliance. Represents Takeda as a clinical GMP
and device subject matter expert during health authority
inspections. Provides strategic direction to assure that responses
are timely and appropriate to maintain Takeda's good standing with
regulatory agencies. Ensures that all inspection commitments are
fulfilled on time.
- Identifies and mitigates quality and compliance issues with
potential significant impact, and ensure that lessons learned are
applied across the network.
- Maintains active interface with global Quality partners to
ensure effective and efficient quality pro- grams to progress
development products into commercialization.
- Determines acceptability of CMOs for potential and/or ongoing
use by Takeda, and provides on- going direction, guidance, and
strategy for supplier oversight.
- This position has overall responsibility for the ongoing
development and operational success of the Pharmaceutical Sciences
and Device Quality, including talent development and succession
planning, resourcing, and budgeting, and alignment of
Pharmaceutical Sciences and Device Quality initiatives with R&D
Quality and Global Quality.
- Leads talent management for Pharmaceutical Sciences and Device
Quality employees across the globe, in partnership with the R&D
Quality Leadership Team and Human Resources Business Partners.
Engage in projects to ensure people development across the
- Serves as a member of the R&D Quality Leadership team,
giving input to key strategic, portfolio, human resource and
- Serves as a strategic thought partner to the Head of R&D
Quality with regard to complex problems affecting development
activities, with an eye to current and future initiatives,
strategies, and budgets.
- Ensure strong alignment with R&D Clinical Quality Assurance
for the oversight of clinical trials.
What you bring to Takeda:
- BS/BA degree and advanced degree preferred.
- Advanced knowledge of clinical Good Manufacturing
- Minimum of 15 years of industry experience in Quality
Assurance, Device and/or clinical trial materials with the majority
in drug research, development, biotechnology, device, or related
- Quality Assurance professional certification/registration
Technical/Functional (Line) Expertise
- Expert knowledge of Good Manufacturing Practice requirements
for clinical trials.
- Advanced experience in auditing CMOs.
- Good working knowledge of device requirements.
- Proficient in analyzing data to identify performance
- Demonstrated ability to succinctly translate and effectively
communicate the potential impact of significant and complex issues.
Proven ability to proactively identify and lead the development and
re-engineering of key processes and systems in support of the
- Highly effective communicator who is capable of establishing a
compelling vision for Pharmaceutical Sciences and Device
- Sets strategy for Pharmaceutical Sciences and Device Quality in
alignment with the priorities of the Takeda Research and in
alignment with the Head, R&D Quality.
- Outstanding leadership and interpersonal skills with a
management style which encourages open expressions of ideas,
opinions, and a full discussion of differing points of view.
- Clear, concise, and consistent in written and verbal
- Ensures that every employee knows what is expected of their
role and what it takes to be successful, and how they are
progressing. Holds employees accountable to achieve results while
demonstrating Takeda's values and strategic priorities of Patient,
Trust, Reputation, and Business.
- Helps employees grow through challenging opportunities so that
they may realize their full potential.
- Serves as a role model for being brave and taking appropriate
risks, always in compliance with applicable regulations and Takeda
Decision-making and Autonomy
- Manages within the department budget established for
Pharmaceutical Sciences and Device Quality, and empowered to make
hiring decisions within allotted headcount.
- Makes organizational design decisions in alignment with the
Head of R&D Quality.
- Experience working within complex organizations, working
closely with senior staff and executive level colleagues. The ideal
candidate will have the acumen to handle complex situations and
multiple responsibilities simultaneously mixing long term projects
with the urgency of immediate demands on the operations. S/he must
also have the demonstrated ability to deal with highly confidential
information and act as a liaison between Head of R&D Quality
and other executives.
- Demonstrated 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
- Ability to read, analyze and interpret common scientific and
technical journals, financial reports, and legal/regulatory
- Effectively presents information to senior management, internal
groups, external stakeholders and customers.
- Leads Research quality oversight for the entire R&D
pipeline around the globe, requiring effective cross-cultural
working skills and expert knowledge of GLP requirements across
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
At 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
- 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
This posting excludes Colorado applicants.
#GMSGQ #ZR1 #LI-MA1
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.
Keywords: Takeda, Boston , Head of Pharmaceutical Sciences and Device Quality (Hybrid), Healthcare , Lexington, Massachusetts
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