Head of Quality Control

Takeda•Lexington, MA

2d•Onsite

About The Position

Join us in leading the future of Quality Control. In this role, you will oversee analytical chemistry, microbiology, and laboratory excellence, driving the highest standards of quality, compliance, and operational performance. Working closely with Manufacturing and Quality partners, you will champion continuous improvement, employee development, and innovation while fostering an inclusive environment where diverse perspectives are valued and everyone is empowered to succeed. The ideal candidate will embody Takeda’s Quality Culture by keeping it simple, encouraging open communication, taking pride in doing it right, and demonstrating an unwavering commitment to quality.

Requirements

Typically requires bachelor's degree, preferably in science, engineering or another related technical field.
10+ years of related experience with 7+ in a management role.
Experience in running a large-scale, multi-function laboratory is strongly preferred.
In depth knowledge of industry standards and regulations related to quality control.
Knowledge of FDA, EMA, CFDA, PDA Regulations, application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).
Manages regulatory inspections and other pre-inspection readiness audits.
Ability to work with multifunctional, global teams in a fast-paced setting.
Good interpersonal/communication/influencing/negotiation skills required.
Strong leadership skills and demonstrated success in managing a large team.
Prior experience in interfacing and/or leading regulatory audits.
Ability to manage department budgets and staffing.
Result driven with ideas to drive continuous improvement and process simplification with breakthrough solutions, including digital.

Nice To Haves

Experience with endotoxin, and sterility testing is preferred.
Knowledge in data analytics and Lean / 6Sigma concepts preferred.
Understanding of new innovated laboratory concepts.

Responsibilities

Lead QC Laboratory operations across Analytical Chemistry and Microbiology.
Drive quality excellence through compliant processes and robust quality systems.
Manage and develop a high-performing 24/7 laboratory team.
Ensure compliance with internal policies, industry standards, and regulatory requirements.
Recruit, coach, mentor, and recognize diverse technical talent.
Partner with senior leadership to strengthen quality systems and resolve complex challenges.
Champion continuous improvement and digital innovation initiatives across QC operations.
Oversee laboratory budgets, contamination control programs, and sterility assurance activities.