Senior Manager, Clinical Program Quality and Excellence (Oncology)

Takeda; United States; On-site; USD 137,000 - 215,000; Full time

Job summary

Takeda seeks a seasoned GCP Quality Assurance professional to oversee quality assurance across global clinical research programs, ensuring inspection readiness for PAI and related activities. You will partner with clinical program teams to deliver risk-based quality guidance and timely investigations.

You will define and implement audit strategies, manage site and vendor audits, escalate critical issues, and support health authority inspections.

Qualifications

• BS/BA required; Advanced Degree preferred.
• Minimum of 7 years in pharma/biotech industry.
• Minimum 5 years of GCP QA or clinical trial experience.
• Extensive knowledge of ICH GCP R2 and global regulations.
• Auditing skills and ability to translate findings into corrective actions.
• Strong communication and matrix leadership abilities.
• Attention to detail and ability to analyze complex data.

Responsibilities

• Provide GCP compliance expertise to program teams and leadership.
• Develop risk-based audit and compliance strategies; manage audits.
• Assess impact of findings on safety, data integrity, and operations.
• Ensure timely audit reports and corrective actions.
• Facilitate investigations and corrective actions; track effectiveness.
• Support GCP health authority inspections and prepare responses.
• Collaborate to identify and mitigate GCP issues across sites.
• Analyze metrics and present to CPMQ management.
• Escalate systemic problems; propose solutions.
• Perform additional GCP activities as needed.

Skills

GCP Quality Assurance

Auditing

Regulatory knowledge

Quality reporting

Risk management

Communication

Project management

Education

BS/BA in life sciences

Advanced degree

Tools

Audit tracking systems

Regulatory databases

Job description

Job Description

• 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.

Benefits

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.