Associate Director, Global Medical Quality (Remote)
Posted on: November 20, 2023
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Job Title: Associate Director, Global Medical Quality
About the role:
As Associate Director, Global Medical Quality, you will be
empowered to lead Quality Assurance activities for assigned
post-marketing research activities performed by Takeda including
the management of audits, quality issues and their investigations,
and inspections. We ask that you have an in-depth of understanding
and experience in both GCP and GVP compliance to conduct
responsibilities independently. You will report to the Head, Global
Medical Quality Pharmacovigilance and Medical Quality.
How you will contribute:
- The research under Global Medical Quality's oversight is
varied. GMQ oversees interventional, observational, prospective and
retrospective studies, and Takeda's Post-authorization Safety
Studies (PASS). You will need a familiarly with these diverse
- Provide professional expertise and guidance on Good Clinical
Practice (GCP) and GVP (Good Pharmacovigilance Practices) and
applicable regulations to post-marketing research activity to
identify compliance issues/risks and recommend mitigations
- Liaise with Takeda R&D functions and external parties
including contract auditors and investigator sites to promote a
high level of quality and consistency across and within programs;
develop the risk-based audit and compliance strategy for assigned
programs; assist project teams in implementing corrective and
preventive actions; and allow teams to be inspection ready, to
support a culture of sustainable compliance.
- Manage domestic and international audits of sites, documents,
databases, vendors or internal systems in compliance with GCP, GVP,
and Takeda procedures; assess impact of audit findings on subject
safety, data integrity, and business operations. Audits conducted
require advanced auditing skills and may involve technically
complex assignments, including audits of high-risk
- Provide expertise in GCP and GVP compliance interpretation,
consultation, training, and recommendations to assigned program
teams and. Ensure implementation of strategies to align with
governing processes, procedures, quality standards and vendor
oversight activities required to maintain compliance with
- Develop and implement risk-based audit and compliance strategy
and manage audits of sites, documents, databases, vendors or
internal systems in compliance with GCP, GVP and Takeda procedures.
Audits require advanced auditing skills and may involve technically
- Assess impact of audit findings and other identified compliance
risks to subject safety, data integrity, and business operations
and escalate compliance risks to CQA management.
- Ensure audit reports and corrective actions are developed and
completed within timelines mandated in internal procedures
- Facilitate investigations into quality issues, scientific
misconduct and serious breach of GCP; facilitate identification of
root cause and development of corrective and preventive actions;
track actions and confirm effectiveness; ensure reporting of
potential or confirmed violations to regulatory authorities.
- Help manage GCP and GVP health authority inspections; lead
clinical teams in preparation for announced inspections and provide
GCP and GVP compliance technical support during inspections of
investigator sites and Takeda. Facilitate appropriate inspection
responses and follow-up actions.
- Present metrics for assigned programs to development teams and
CQA management; recommend any required actions and monitor
- Escalate systemic and important problems and recommend
appropriate solutions to senior management for immediate and
- Perform additional GCP and GVP related activities upon request
by GMQ management, including aspects of vendor qualification.
What you bring to Takeda:
- Bachelor's Degree required; Advanced Degree.
- Minimum BS/BA degree with advanced scientific degree
- Minimum of 8 years of increasing responsibility in
pharmaceutical, GCP- and/or GVP related Quality environment.
- In-depth knowledge of the applicable GVP/GCP regulations
- Demonstrate advanced knowledge in the conduct and reporting of
audits and the translation of findings into corrective actions
plans that mitigate risks to the company, to safety and data
- Have the necessary science education and knowledge to provide
QA oversight of clinical trials and pharmacovigilance activities,
and to assure ethical treatment of subjects. Understand medical
terminology and is familiar with standards of care and disease
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 environments requiring special gowning.
Will be required to follow gowning requirements and wear protective
clothing over the head, face, hands, feet and body
- No make-up, jewelry, contact lenses, nail polish or artificial
fingernails may be worn in the manufacturing environment.
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.
USA - MA - Cambridge - Kendall Square - 500
Keywords: Takeda, Cambridge , Associate Director, Global Medical Quality (Remote), Healthcare , Cambridge, Massachusetts
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