Strategic Quality Leader for Compliance & Inspection Readiness

Socket.dev; Macungie (Lehigh County); On-site; USD 130,000 - 200,000; Full time

Job summary

Socket.dev seeks an Associate Director of Quality to lead the site’s Pharmaceutical Quality System, ensuring global regulatory compliance, customer expectations, and corporate standards.

As the senior quality leader, you will drive a culture of quality, risk management, and inspection readiness, partnering across Operations, Engineering, and Supply Chain to deliver compliant products and services to customers.

Qualifications

• Demonstrated knowledge and application of FDA cGMP/GCP regulations, EMA, ICH, and 21 CFR Part 11 in manufacturing/packaging.
• Strong leadership and cross-functional change management experience.
• Excellent verbal and written communication suitable for non-technical audiences.

Responsibilities

• Provide leadership for Quality Assurance, Quality Systems, Compliance, and Validation.
• Act as the site’s senior Quality authority ensuring regulatory compliance and patient safety.
• Oversee quality systems, deviations, investigations, CAPAs, change controls, and document control.
• Lead inspection readiness, regulatory inspections, and customer audits.
• Partner with Operations, Engineering, Supply Chain, and Commercial teams to ensure compliant product delivery.

Skills

FDA cGMP/GCP regs

Quality leadership

Regulatory compliance

Root cause analysis

Communication skills

Education

Bachelor's degree in science

Job description

Socket.dev seeks an Associate Director of Quality to lead the site’s Pharmaceutical Quality System, ensuring global regulatory compliance, customer expectations, and corporate standards.

As the senior quality leader, you will drive a culture of quality, risk management, and inspection readiness, partnering across Operations, Engineering, and Supply Chain to deliver compliant products and services to customers.