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Job DescriptionOBJECTIVES:
Provides quality assurance oversight of the global clinical research programs in Research and Development (R&D), Plasma Derived Therapy (PDT), Vaccines Business Unit (VBU), Oncology Business Unit (OBU) and Global Medical Marketed Products Development (MPD) with the overall goal of inspection readiness.
Serves as a Strategic Quality Thought Partner to Clinical Program Teams and other key stakeholders in the delivery of the clinical research programs, providing professional clinical research quality expertise and risk-based advice.
With the guidance of Head of Clinical Program Quality, TAU, defines and implements a risk-based program audit strategy, ensuring communication of significant quality and compliance risks to key stakeholders and Management and appropriate and timely investigations and mitigations are in place.
Leads the clinical pre-approval inspection (PAI) readiness programs, the management of the inspection and the response and follow-up activities. Ensures that any inspection risks are well-communicated and mitigated. These inspections include both sponsor and investigator sites.
ACCOUNTABILITIES:
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, clinical trial delivery, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and may involve technically complex assignments.
Assess impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations and escalate compliance risks to CPMQ management.
Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures
Facilitate 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.
Assist with management of GCP health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Takeda. Facilitate appropriate and timely inspection responses and follow-up actions.
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 functional groups.
Analyse, report, and present metrics for assigned programs to development teams and CPMQ management; recommend any required actions and monitor implementation.
Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Perform additional GCP related activities upon request by CPMQ management
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/BA required; Advanced Degree preferred.
Minimum of 7 years of experience in the pharmaceutical, biotechnology or related health care industry.
Minimum 5 years of GCP-related Quality Assurance or relevant clinical trial experience.
Extensive knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development
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 integrity.
Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
Effective technical writing skills; able to write quality positions, audit reports, and procedures.
Excellent communication skills with ability to negotiate and influence without authority in a matrix environment
Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
Superior attention to detail and ability to analyse complex data
LICENSES/CERTIFICATIONS:
GCP Quality Assurance registration/certification preferred
PHYSICAL DEMANDS:
Routine demands of an office-based environment
TRAVEL REQUIREMENTS:
Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
Requires approximately 30% travel.
Takeda Compensation and Benefits Summary
We 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:
USA - MA - VirtualU.S. Base Salary Range:
$137,000.00 - $215,270.00The 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.
For information about our benefits, please click here.
EEO Statement
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.
LocationsUSA - MA - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Skills Required
- Bachelor’s degree in a relevant field (BS/BA)
- Minimum 7 years of experience in the pharmaceutical, biotechnology, or related healthcare industry
- Minimum 5 years of GCP-related quality assurance or relevant clinical trial experience
- Extensive knowledge of ICH GCP R2 and applicable global clinical development regulations and guidance
- Advanced knowledge of audit conduct, audit reporting, and translating findings into corrective action plans
- Effective technical writing skills for quality positions, audit reports, and procedures
- Excellent communication, negotiation, and influencing skills in a matrix environment
- Strong judgment, project management, and decision-making skills
- Superior attention to detail and ability to analyze complex data
- Advanced degree
- GCP quality assurance registration or certification
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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