Senior Manager, Clinical Program Quality and Excellence (Oncology)

About the role

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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 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: P rovide   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 C PM Q 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;   en sure 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 pr ovide GCP   compliance technical support during inspections of investigator sites and Takeda.   Facilitate   appropriate   and   timely   inspection   response s   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,   r epor t, and present   metrics for assigned   programs   to   development teams and C PMQ   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 C PM Q management   EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: BS/BA   require d; Advanced Degree preferred.   Minimu m   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.  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. #LI-Remote