Senior Manager, Clinical Program Quality and Excellence (Oncology)

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

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U.S. Base Salary Range:

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.

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