Assoc Director, Clinical and Safety Quality Compliance

Assoc Director, Clinical and Safety Quality Compliance

Location : Cambridge, MA

• Hybrid (not remote). Relocation Benefit is available.

Base pay range : $153,600.00 / yr - $241,340.00 / yr

Overview

The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, auditing and monitoring processes, and ensuring compliance with corporate and regulatory standards. By maintaining high-quality standards, this role supports Takeda's mission to provide better health and a brighter future.

How Will You Contribute

Ensure compliance to Regulatory Intelligence Procedures by executing the regulatory intelligence process in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by compliance to regulatory intelligence procedures.

Ensure a robust communication plan is in place (including brief description of the new and / or revised regulations, impact, risks, mitigation plans, timelines) that enables knowledge sharing of regulatory intelligence insights and risks across CPMQ. Communicates periodically the progress of new and revised regulations and impact.

Ensure implementation of change control and actions completed to address new and revised regulations. Oversees the review, completion and closure of routine and complex, impactful strategic clinical-related change controls and strategic Pharmacovigilance-related change controls.

Provide data insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identify quality and compliance risks, and proactively provide strategic and tactical directions in mitigation.

Actively participate and contribute to enterprise-wide projects and initiatives, ensuring insights related to clinical and safety quality are considered.

Enable a compliant quality system in safety and clinical trial delivery systems via CPMQ continual improvements projects. Actively participate and represent in continual improvement projects, related to safety and clinical trial delivery in partnership with GDO, PSPV, GRA, etc. Review the outputs of the safety and clinical trial delivery redesigned processes and coordinate CPMQ colleagues’ input.

Provide CPMQ insights on continuous improvement that are enterprise-wide (e.g., Veeva, QMS, Enterprise Audit) to Global Quality and R&D Quality. Present to CPMQ at periodic intervals the status, insights and impact of projects impacting clinical and safety quality.

Actively identify key areas for process improvements and develop and execute plans according to timelines. Support the implementation of new and revised processes across CPMQ.

Contribute to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations as a key member of the Leadership Team.

What You Bring To Takeda

BSc in a scientific or allied health / medical field (or equivalent degree).

Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality / Compliance.

Advanced knowledge of pharmaceutical development, medical affairs and GCP / GVP regulations including FDA, EU, MHRA, PMDA and ICH.

Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting / leading regulatory inspections, investigations and remediation activities on a global level.

Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.

Skilled in managing global, cross-functional projects.

Successful management of business transformation / change management initiatives e.g., quality system integration, outsourcing strategy, etc.

Excellent communication skills to convey messages. Exceptional active listening skills to understand the needs and concerns of others, which is crucial for finding win-win solutions.

Outstanding ability to apply critical thinking and problem-solving abilities to address challenges and advocate for solutions.

Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues.

Fluency in written and spoken English; additional language skills are a plus.

Compensation and Benefits

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 strive to be more transparent with pay practices.

Location : Boston, MA

U.S. Base Salary Range : $153,600.00 - $241,340.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on factors including qualifications, years of relevant experience, skills, education, certifications, and location. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and / or long-term incentives, medical / dental / vision insurance, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, and well-being benefits. U.S. based employees may be eligible to accrue paid time off and vacation per calendar year.

EEO Statement

Takeda is committed 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 veteran, or other protected status in accordance with applicable laws.

Locations : Boston, MA | Worker Type : Employee | Worker Sub-Type : Regular | Time Type : Full time

Seniority level

Director

Employment type

Full-time

Job function

Management and Manufacturing

Industries

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