Associate Director, Clinical Program Quality and Excellence (Oncology)

We need to output HTML fragment with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Remove boilerplate like application instructions, EEO, etc. Must preserve all substantive info. We need to parse the posting. Key sections: - Job Description: OBJECTIVES: ... (this is about role). Could be "About the role". Provide description. - ACCOUNTABILITIES: list of duties/responsibilities. That's responsibilities. - EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: includes education, experience, competencies, skills. Could split into Requirements (education, experience), Qualifications (maybe advanced degree preferred?), Skills (technical writing, communication, etc). But we need to follow instruction: Use headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what goes where. We have: - About the role: The objectives paragraph. - Responsibilities: The ACCOUNTABILITIES bullet list. - Requirements: Education (BA/BS required; advanced degree preferred), Minimum 10 years experience, Minimum 7 years GCP QA experience, etc. Also licenses/certifications: GCP QA registration/certification preferred. Physical demands, travel requirements maybe schedule? Travel is schedule? Travel requirement could be in Schedule? But schedule heading is for work schedule (full-time, etc). Travel is not schedule but maybe we can put under Requirements? However instruction: include Schedule section only if posting actually states them. The posting mentions "Time Type: Full time", "Job Exempt: Yes", "Worker Type: Employee", "Worker Sub-Type: Regular". Also "Travel Requirements: Willingness to travel... Approximately 30% travel." That's travel, not schedule. Schedule could be "Full time". So we can include Schedule section with "Full time". Also maybe location: Massachusetts - Virtual. - Qualifications: Could be advanced degree preferred, GCP QA registration/certification preferred, etc. But we already have education in Requirements. Might combine. However we need to avoid thin sections. Perhaps we can put education+experience under Requirements, and certifications/licenses under Qualifications, and behavioral competencies/skills under Skills. Thus: Requirements: BA/BS degree required; advanced degree preferred. Minimum 10 years experience in pharma/biotech/healthcare. Minimum 7 years of GCP-related QA or relevant clinical trial experience. Qualifications: GCP Quality Assurance registration/certification preferred. Skills: Collaborative team player, stakeholder management, positive attitude, critical thinking, ability to think/act quickly, creative solutions, strong technical writing, excellent communication, ability to negotiate/influence without authority, strong judgment, project management, decision-making, manage multiple projects/demanding timelines, superior attention to detail, ability to analyze complex data. Also maybe "Advanced knowledge in the conduct and reporting of audits and translation of findings into corrective actions plans" could be skill. Benefits: The posting says "Benefits For information about our benefits, please click here." No actual benefits listed. So we should NOT create Benefits section because no specific content. According to instruction: never create Benefits section unless posting actually states them. It only says "For information about our benefits, please click here." That's not substantive. So omit Benefits. Pay: There is a compensation summary: "For Location: Massachusetts - Virtual U.S. Base Salary Range : $154,400.00 - $242,550.00". Also description about factors. That's substantive. So include Pay section with that range and note. Schedule: We have "Time Type: Full time", "Job Exempt: Yes". Also maybe "Worker Type: Employee", "Worker Sub-Type: Regular". So we can put Schedule: Full time, Exempt position. Also location maybe not needed. We must not include boilerplate like EEO, legal, etc. Also remove duplicated lines. Now produce HTML fragment with

headings and appropriate

or

• . We need to preserve all substantive information. Let's extract details. About the role (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." We'll put that as

  maybe multiple paragraphs. Responsibilities (ACCOUNTABILITIES): list items: - Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams - Assume complex assignments on issues or studies where there is no precedent - Mentor and provide support to Manager level CPQ personnel, as needed - Represent CPQ in program-specific meetings and global CPQ team assigned - Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, clinical study delivery, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and 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 CPMQ management. - Ensure audit reports and corrective actions are developed and completed within timelines mandated in internal procedures - Lead 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. - Lead 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 - Analyse, report, and present metrics for assigned programs to development teams R&D, and Quality management; recommend any required actions and monitor implementation. - Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs, Takeda sites, or functional groups. Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution - Participate in due diligence activities and process improvement initiatives as requested by management - May act as supervisor for temporary contractors We'll put each as

• . Requirements: - BA/BS degree required; advanced degree preferred. - Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry. - Minimum 7 years of GCP-related Quality Assurance or relevant clinical trial experience. Maybe also include "Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development" but that's more skill/knowledge. Could be under Requirements as knowledge requirement. But we already have Skills section for competencies. Might put knowledge under Requirements as well. However to avoid thin sections, we could combine knowledge under Requirements. Let's decide: Requirements: education, experience, knowledge of ICH GCP, etc. Qualifications: certifications. Skills: behavioral/competencies. Thus Requirements: - BA/BS degree required; advanced degree preferred. - Minimum 10 years experience in pharma/biotech/healthcare. - Minimum 7 years GCP-related QA or relevant clinical trial experience. - Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development. Qualifications: - GCP Quality Assurance registration/certification preferred. Skills (behavioral/competencies): - Collaborative team player, comfortable with stakeholder management, with a positive attitude, critical thinking skills and the ability to think and act quickly to identify creative solutions to complex problems - Strong 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 analyze complex data - 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. Pay: - For Location: Massachusetts - Virtual U.S. Base Salary Range : $154,400.00 - $242,550.00 - 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. Schedule: - Time Type: Full time - Job Exempt: Yes - Worker Type: Employee - Worker Sub-Type: Regular - Travel Requirements: Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required. Requires approximately 30% travel. But Travel is not schedule; but we have no separate Travel heading. Could include under Schedule as "Travel: approx 30%". Or we could add a separate section? Not allowed headings beyond those listed. So we can include travel under Schedule as note. Thus Schedule section includes full time, exempt, employee, regular, travel approx 30%. Now produce HTML. We must not include any markdown fences. Just raw HTML. Let's craft:

  About the role

  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.

  Responsibilities

  • Provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned high priority development program teams
  • Assume complex assignments on issues or studies where there is no precedent
  • Mentor and provide support to Manager level CPQ personnel, as needed
  • Represent CPQ in program-specific meetings and global CPQ team assigned
  • Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, clinical study delivery, documents, databases, vendors or internal systems in compliance with GCP and Takeda policies and procedures. Audits require advanced auditing skills and involve technically complex assignments.