Overview

Director R&D Quality Compliance Risk Mgt – Takeda

Join to apply for the Director R&D Quality Compliance Risk Mgt role at Takeda.

Base pay range: $174,500.00/yr - $274,230.00/yr. Location: Boston, MA. This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Responsibilities

• Partner cross-functionally to enable transparency and evaluation of R&D Quality risks and issues. Collaborate with functional leads to address challenges, provide enterprise-wide assessments, and support development and execution of action plans to address risks.
• Lead the implementation and management of an aligned Quality Risk Management program in R&D Quality. Provide assessment, insight and recommendations on risks across the R&D enterprise to senior R&D Quality management.
• Collaborate with R&D Quality personnel on compliance issues, audits/inspections, regulatory risk assessments, and process improvement opportunities.
• Develop and oversee R&D Quality metrics reporting on the state of compliance. Drive continuous quality improvements and risk mitigations through audit/inspection findings, quality event outcomes, and trend analysis.
• Partner with Global Quality Compliance and Systems as R&D Quality process owner for regulatory intelligence; ensure robust implementation to maintain compliance with evolving global regulations.
• Coordinate information flow and consolidate Quality Councils into an enterprise-wide view; extract data/issues/risks and develop executive-level assessments for leadership review.
• Support multi-year organizational strategy for the R&D Quality Compliance, Systems, and Data organization.
• Undertake additional duties as assigned to contribute to organizational success.

Education & Competencies

• Minimum requirements
• Bachelor’s Degree in Chemistry, Biology, Engineering or related field
• 10+ years of increasing responsibility in the biopharma/biotech industry
• 8+ years of Quality/Compliance experience

• Preferred requirements
• Advanced degree in Chemistry, Biology, Engineering or related field
• Prior people-management experience

• Desired skills & competencies
• In-depth knowledge of global regulations governing biopharmaceutical R&D and Quality Management Systems; ability to translate strategies to ensure compliance.
• Knowledge of data visualization and analytics to monitor performance and drive data-driven decisions.
• Proven leadership, collaboration, and influencing skills; ability to solve problems and drive change.
• Ability to work with diverse stakeholders across organizational levels; strong interpersonal, verbal, and written communication.
• Adaptability to dynamic environments; ability to manage multiple projects and deliverables on time.
• Attention to detail and organizational expertise; ability to work independently across global settings and influence without authority.

Compensation & Benefits

Takeda Compensation and Benefits Summary: U.S. Base Salary Range: $174,500.00 - $274,230.00. Location: Boston, MA. The actual base salary offered depends on qualifications, experience, skills, education, and location. U.S. based employees may be eligible for incentives and comprehensive benefits (medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, holidays, and well-being benefits).

EEO Statement: Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or protected veteran status, in accordance with applicable laws.

Locations: Boston, MA

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time

Job Exempt: Yes

Note: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment.

Seniority level

• Director

Employment type

• Full-time

Job function

• Quality Assurance
• Industries: Pharmaceutical Manufacturing

Other job postings and related notices may be listed for context but are not part of this role description.