Unknown Company

Head of Quality Control

lexington, ma • Posted 2 weeks ago
Onsite Full Time Quality Management & Operations

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.

#J-18808-Ljbffr

Head of Quality Control in lexington at Unknown Company

This position is listed as full time and onsite.

Back to Job Search