Senior Manager, Clinical Program Quality and Excellence (Oncology)

Regulatory Jobs; Massachusetts; Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda is seeking an experienced GCP Quality Assurance professional to provide expert oversight of global clinical research programs and lead inspection readiness activities. The role requires strong audit leadership, risk-based thinking, and collaboration across clinical teams, with 30% travel and a base salary in the USA-MA virtual environment.

You will interpret GCP guidance, manage audit activities, and support regulatory inspections with timely, compliant responses and corrective actions.

Qualifications

• BS/BA required; Advanced Degree preferred.
• Minimum 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 of ICH GCP R2 and applicable global regulations and guidance for clinical development.
• Advanced knowledge in conduct and reporting of audits and corrective action plans.

Responsibilities

• 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.
• Assess impact of audit findings and other compliance risks to subject safety, data integrity, and business operations; escalate to CPMQ management as needed.
• Ensure audit reports and corrective actions are developed and completed within timelines.
• Facilitate investigations into significant quality issues and breaches of GCP; identify root causes and develop corrective and preventive actions.

Job description

Job Description

OBJECTIVE S:

• 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 qualityexpertiseand risk-based advice.

• With theguidanceof 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 andappropriateandtimelyinvestigations 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:

• ProvideexpertiseinGCP compliance interpretation, consultation, training, and recommendationsto assigned program teamsandleadership

• Developand implementprogram-specific risk-based audit and compliance strategy andmanageaudits of sites,clinical trial delivery,documents, databases,vendorsor internal systems in compliance withGCPand Takeda policies and procedures.Audits require advanced auditing skills and may involve technically complex assignments.

• Assess impact of audit findingsand other identified compliance risks tosubject safety, data integrity, and business operationsand escalation compliance risks to CPMQ management.

• Ensureauditreports and corrective actions are developed and completed within timelines mandated in internal procedures

• Facilitateinvestigations intosignificant quality issues,scientificmisconductand serious breach of GCP;facilitateidentification ofroot causeand development ofappropriate correctiveand preventiveactions;track actions and confirm effectiveness;ensure reporting of potential or confirmed violations to regulatory authorities.

• Assistwith management ofGCPhealth authorityinspections;lead clinical development teams in preparation for announced inspections and provide GCPcompliance technical support during inspections of investigator sites and Takeda.Facilitateappropriateandtimelyinspectionresponsesandfollow-up actions.

• Collaborate withQualityCompliance and Systemsteamtoidentifyand mitigate GCP quality and compliance issues withpotential impact across multiple compounds,Takedasites, or functional groups.

• Analyse,report, and presentmetrics for assignedprogramstodevelopment teams and CPMQmanagement;recommend any required actionsand monitor implementation.

• Escalatesystemicand/or criticalproblemsand recommendappropriate solutionstoseniormanagement for immediate and long-term resolution

• PerformadditionalGCPrelatedactivitiesuponrequest by CPMQ management

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS/BArequired; Advanced Degree preferred.

• Minimumof 7yearsofexperience in the pharmaceutical,biotechnologyor related health careindustry.

• Minimum5 years of GCP-related Quality Assuranceor relevant clinical trialexperience.

• Extensive knowledge and/or awareness ofICH GCP R2andapplicable globalregulationsand 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 toidentifycreative solutions to complex problems

• Effectivetechnical writingskills; able to write quality positions, audit reports, and procedures.

• Excellent communication skillswith ability to negotiate and influencewithout authorityin a matrix environment

• Strong judgment, projectmanagementand decision-making skills; able to manage multiple projects and demanding timelines

• Superiorattention to detail and ability to analyse complex data

LICENSES/CERTIFICATIONS:

• GCP Quality Assurance registration/certification preferred

PHYSICAL DEMANDS:

• Routine demands of an office-basedenvironment

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may berequired.

• 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 - Virtual

U.S. Base Salary Range:

$137,000.00 - $215,270.00

The 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.

Locations

USA - MA - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It 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.