Program Manager, Clinical Quality Assurance
Posted on: November 20, 2023
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Job Title: Program Manager, Clinical Quality Assurance
Location : Cambridge, MA
About the role:
As the Program Manager, Clinical Quality Assurance, you will lead
Clinical Quality Assurance (CQA) activities for assigned clinical
development programs, including the management of audits, quality
issues and investigations, and inspections. This position requires
sufficient understanding, experience in GCP and compliance,
leadership, communication skills, and business acumen to conduct
responsibilities with supervision. You will report to the Head of
Gastrointestinal and Inflammation, Clinical Quality Assurance.
How you will contribute:
- Provide expertise and guidance on Good Clinical Practice (GCP)
and applicable regulations to clinical development teams to
proactively identify compliance issues/risks and recommend
- Liaise with various 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 enable teams to be inspection ready, in
support of a culture of sustainable compliance.
- Manage domestic and international audits of sites, documents,
databases, vendors or internal systems in compliance with GCP and
Takeda policies and procedures; assess impact of audit findings on
subject safety, data integrity, and business operations.
- Provide expertise in GCP compliance interpretation,
consultation, training, and recommendations to assigned program
teams and leadership
- Develop and implement program-specific risk-based audit and
compliance strategy and manage audits of sites, documents,
databases, vendors or internal systems in compliance with GCP and
Takeda policies and procedures.
- 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
- Assist with investigations into significant quality issues,
scientific misconduct and serious breach of GCP; facilitate
identification of root cause and development of appropriate
corrective and preventive actions; track actions and confirm
effectiveness; ensure reporting of potential or confirmed
violations to regulatory authorities.
- Provide GCP compliance support during inspections of
investigator sites and Takeda. Assist with development of
appropriate and timely inspection responses and follow-up
- Collaborate with Quality Compliance and Systems team to
identify and mitigate GCP quality and compliance issues with
potential impact across multiple compounds, Takeda sites, or
- Analyze, report, and present metrics for assigned programs to
development teams and CQA management; recommend any required
actions and monitor implementation.
- Escalate systemic and/or critical problems and recommend
appropriate solutions to senior management for immediate and
- Perform additional GCP related activities upon request by CQA
What you bring to Takeda:
- BS/BA degree required; advanced degree preferred.
- Minimum of 5 years of experience in the pharmaceutical,
biotechnology or related health care industry.
- Minimum 2 years of GCP-related Quality Assurance or relevant
clinical trial experience.
- Knowledge and/or awareness of ICH GCP R2 and applicable global
regulations and guidance for clinical development
- Knowledge of conduct and reporting of audits and the
translation of findings into corrective actions plans that mitigate
risks to the company, to safety and data integrity.
- Collaborative team player with a positive attitude
- Effective technical writing skills; able to write quality
positions, audit reports, and procedures.
- Ability to analyze complex data
- GCP Quality Assurance registration/certification preferred.
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:
- Routine demands of an office-based environment
- Willingness to travel to various meetings and/or audits,
including overnight trips. Requires approximately 30% travel. Some
international travel may be required
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 , Program Manager, Clinical Quality Assurance, Executive , Boston, Massachusetts
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