Head of Quality Control

Scorpion Therapeutics; Lexington (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Scorpion Therapeutics in Lexington, MA, is seeking a senior leader to head QC Laboratory operations across Analytical Chemistry and Microbiology. You will drive quality excellence, implement robust quality systems, and partner with senior leadership to strengthen quality controls in a fast-paced, regulated environment.

You will recruit, coach, and mentor a 24/7 lab team, oversee budgets and calibration programs, and advance continuous improvement, digital innovation, and readiness for regulatory

Qualifications

• Bachelor’s degree in science/engineering or related field
• 10+ years experience with 7+ years in a management role
• Experience in large-scale, multi-function laboratory environment
• Deep knowledge of QC regulations/standards: FDA/EMA/CFDA/PDA; cGMP
• Experience leading regulatory inspections and audits
• Preferred: endotoxin and sterility testing experience
• Ability to lead global multifunctional teams in fast-paced settings
• Strong leadership, communication, and influencing skills
• Budgeting and staffing management experience
• Lean/6Sigma or data analytics knowledge is a plus

Responsibilities

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

Skills

Leadership

Communication

Team management

Regulatory knowledge

Cross-functional collaboration

Negotiation

Education

Bachelor’s degree in science/engineering

Job description

Responsibilities:

• Lead QC Laboratory operations across Analytical Chemistry and Microbiology.
• Drive quality excellence via 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 technical talent.
• Partner with senior leadership to strengthen quality systems and resolve complex challenges.
• Champion continuous improvement and digital innovation across QC operations.
• Oversee lab budgets, contamination control programs, and sterility assurance activities.

Qualifications & Skills:

• Bachelor’s degree (science/engineering/related preferred).
• 10+ years related experience, with 7+ years in a management role.
• Strong preference: large-scale, multi-function laboratory experience.
• In-depth knowledge of quality control regulations/standards; FDA/EMA/CFDA/PDA; GDDP; cGMP.
• Manage regulatory inspections and pre-inspection readiness audits; lead/interfacing with regulatory audits.
• Preferred: endotoxin and sterility testing experience.
• Ability to work with multifunctional global teams in a fast-paced setting.
• Strong leadership and interpersonal/communication/influencing/negotiation skills.
• Ability to manage department budgets and staffing.
• Preferred: data analytics; Lean/6Sigma; knowledge of innovative lab concepts.

Important considerations:

• Controlled environment gowning/PPE; cold/wet environment; multiple shifts/weekends; chemical exposure/respiratory protection as required; ~10% travel.