Senior Manager, Clinical Program Quality and Excellence (Oncology)

USA - 3316 Takeda Development Center Americas, Inc.; Massachusetts; Hybrid; USD 137,000 - 215,000; Full time

Job summary

Takeda seeks a Quality Assurance professional to drive GCP compliance across global clinical research programs, leading audits, and ensuring inspection readiness. You will partner with the Head of Clinical Program Quality to design risk-based strategies and guide investigations while communicating findings to senior stakeholders.

The role requires 7+ years in pharma/biotech QA, ICH GCP knowledge, and strong writing/communication skills. Travel may be required as part of audits and inspections.

Qualifications

• Minimum of 7 years in pharma/biotech with clinical QA experience.
• Extensive knowledge of ICH GCP R2 and global regulations.
• Proven ability to lead audits and develop CAPAs.
• Strong technical writing and communication skills.
• Ability to manage multiple projects with tight timelines.

Responsibilities

• Define and implement risk-based audit strategy for programs.
• Lead pre-approval inspection readiness and manage inspections.
• Escalate critical issues to CPMQ management with recommended actions.
• Collaborate with Quality Compliance to mitigate GCP issues.
• Develop metrics and report program status to leadership.

Skills

GCP compliance

Audit & QA

Project management

Technical writing

Communication

Collaboration

Risk assessment

Education

BS/BA in related field

Advanced degree preferred

Job description

Job Description OBJECTIVES:

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 elevate 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 - 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.

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.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.