Head of Quality Control

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.

• 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/6
  
  Sigma; knowledge of innovative lab concepts.

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