Head of Quality Control
About the role
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.
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.
Requirements
- Typically requires a 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).
- Experience with regulatory inspections and other pre-inspection readiness audits.
- Experience with endotoxin, and sterility testing is preferred.
- 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.
- Knowledge in data analytics and Lean / 6Sigma concepts preferred.
Qualifications
- Typically requires a 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).
- Experience with regulatory inspections and other pre-inspection readiness audits.
- Experience with endotoxin, and sterility testing is preferred.
- 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.
- Knowledge in data analytics and Lean / 6Sigma concepts preferred.
Skills
- Leadership skills.
- Communication skills.
- Interpersonal skills.
- Project management skills.
- Quality control expertise.
- Data analysis skills.
- Lean / 6Sigma concepts.
Benefits
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Pay
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. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
Schedule
Full-time, regular time.
Location
USA - MA - Lexington - BIO OPS