Associate Director, Clinical Program Quality and Excellence (Oncology)

Regulatory Jobs; Massachusetts; Remote; USD 154,000 - 243,000; Full time

Job summary

Regulatory Jobs in Massachusetts is seeking an experienced Quality Assurance leader to oversee global clinical research programs and ensure inspection readiness. You will serve as a strategic partner, guiding risk-based audit strategies and managing pre-approval inspections for sponsor and site activities.

The role requires 10+ years in pharma/biotech with 7+ years in GCP QA, strong writing and communication skills, and the ability to mitigate complex compliance risks across programs.

Qualifications

• Minimum of 10 years of experience in the pharmaceutical/biotech industry.
• Minimum 7 years in GCP-related Quality Assurance or clinical trial QA.
• Extensive knowledge of ICH GCP and global regulations for clinical development.
• Ability to translate audit findings into corrective actions and mitigations.
• Strong written communication and ability to influence in a matrix environment.

Responsibilities

• Provide GCP compliance interpretation, consultation, training and recommendations.
• Lead program-specific risk-based audit and compliance strategy across sites.
• Manage audits of clinical delivery, documents, databases, vendors and systems.
• Lead investigations into quality issues and oversee corrective actions.
• Prepare for and support GCP health authority inspections and responses.
• Analyze metrics and communicate findings to teams and management.
• Escalate systemic problems and propose timely solutions.

Skills

GCP compliance expertise

Auditing and investigations

Strong communication skills

Risk-based thinking

Quality system knowledge

Education

BA/BS degree required

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 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 elevate 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

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 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.
• Extensive knowledge and/or awareness of ICH GCP 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, 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

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:

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.

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt 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.