QC Program Lead – FDA-Regulated Lab

Haleon plc.; East Durham (NY); On-site; USD 130,000 - 178,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Parental leave

Healthcare coverage

Discretionary bonus

Job summary

Haleon plc. seeks a senior Laboratory Quality leader to oversee all QC activities, ensure compliance with FDA/DEA and internal standards, and drive continuous improvement in the lab.

You will lead investigations, interact with regulators, manage resources, and guide analytical methods validation and equipment calibration. You will develop strategy and operational plans for the department, coach the team, and ensure effective cross-site communication while upholding Haleon’s quality and

Qualifications

• Bachelor’s degree in science or relevant field.
• 8 years of experience in an FDA regulated industry.
• Minimum of 5 years’ management experience.
• Knowledge of cGMP’s/FDA and ICH Guidelines 8, 9, 10, 11.

Responsibilities

• Plan, organize, direct and control lab activities to ensure compliance with policies and regulations.
• Act as QC representative during FDA/DEA inspections and internal audits.
• Ensure testing of raw materials, finished products and microbiological testing aligns with SOPs.
• Lead complex laboratory investigations including OOS and OOT.
• Interact with Regulators and internal auditors.
• Develop analytical development programs and drive CI across the lab.
• Oversee budgeting, headcounts, expenses and asset utilization.
• Lead and mentor the QC department with performance management and training.

Skills

Quality control

Regulatory knowledge

Project management

Leadership

Analytical skills

Communication

Teamwork

Problem solving

Education

Bachelor’s degree in science

8 years FDA regulated experience

5 years management experience

Job description

Haleon plc. seeks a senior Laboratory Quality leader to oversee all QC activities, ensure compliance with FDA/DEA and internal standards, and drive continuous improvement in the lab.

You will lead investigations, interact with regulators, manage resources, and guide analytical methods validation and equipment calibration. You will develop strategy and operational plans for the department, coach the team, and ensure effective cross-site communication while upholding Haleon’s quality and