Senior Quality & Compliance Leader

Sharp Packaging Solutions, part of UDG Healthcare plc; Macungie (Lehigh County); On-site; USD 140,000 - 190,000; Full time

Job summary

Sharp Packaging Solutions, part of UDG Healthcare plc, seeks an Associate Director of Quality to provide strategic leadership of the site’s Pharmaceutical Quality System (PQS) and ensure compliance with global regulatory requirements, customer expectations, and company standards.

The role serves as the senior quality leader for the site, fostering a culture of quality, continuous improvement, risk management, and inspection readiness across operations, collaborating with Operations, Engineering,

Qualifications

• FDA cGMP/GCP, EMA, ICH, and 21 CFR Part 11 compliance knowledge.
• Strong team management and cross‑functional change experience.
• Excellent verbal and written communication with ability to present to non-technical audiences.

Responsibilities

• Provide leadership for QA, Quality Systems, Compliance, and Validation.
• Maintain Pharmaceutical Quality System meeting regulatory and customer requirements.
• Lead inspections, regulatory interactions, and customer audits.
• Drive risk management, CAPA, investigations, and management review.
• Partner with Operations, Engineering, Supply Chain to ensure product quality.

Skills

Quality leadership

Regulatory compliance

cGMP knowledge

Cross-functional leadership

FDA regulations

Communication skills

Education

BS/BA in science

Job description

Sharp Packaging Solutions, part of UDG Healthcare plc, seeks an Associate Director of Quality to provide strategic leadership of the site’s Pharmaceutical Quality System (PQS) and ensure compliance with global regulatory requirements, customer expectations, and company standards.

The role serves as the senior quality leader for the site, fostering a culture of quality, continuous improvement, risk management, and inspection readiness across operations, collaborating with Operations, Engineering,