Senior Director, Quality & Regulatory Excellence

Sharp Services, LLC; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Sharp Services, LLC in Macungie, PA is seeking an Associate Director of Quality to lead the site's Pharmaceutical Quality System and ensure regulatory compliance. This role serves as the senior quality leader and collaborates with Operations, Engineering, Supply Chain, and Commercial teams to deliver compliant products.

The ideal candidate will drive continuous improvement, risk management, and inspection readiness, while maintaining patient safety and product quality in a fast-paced

Qualifications

• Demonstrated knowledge of FDA cGMP/GCP regulations, EMA, ICH.
• Strong leadership and cross-functional change management.
• Excellent communication and documentation skills.

Responsibilities

• Provide leadership for QA functions including QA, Quality Systems, Compliance and Validation.
• Lead independent quality oversight for patient safety and regulatory compliance.
• Maintain Pharmaceutical Quality System meeting cGMP and regulatory requirements.
• Oversee deviations, investigations, CAPAs, change controls, and audits.
• Prepare for inspections and manage customer audits.

Skills

FDA cGMP

Team management

Communication

Regulatory compliance

Problem solving

Education

BS/BA in science

Job description

Sharp Services, LLC in Macungie, PA is seeking an Associate Director of Quality to lead the site's Pharmaceutical Quality System and ensure regulatory compliance. This role serves as the senior quality leader and collaborates with Operations, Engineering, Supply Chain, and Commercial teams to deliver compliant products.

The ideal candidate will drive continuous improvement, risk management, and inspection readiness, while maintaining patient safety and product quality in a fast-paced