Senior Quality Leader, Compliance & Strategy

Sharp Clinical Services; Macungie (Lehigh County); On-site; USD 140,000 - 200,000; Full time

Job summary

Sharp Clinical Services, located in Lehigh County, seeks an Associate Director of Quality to lead the Pharmaceutical Quality System and ensure global regulatory compliance. You will partner with Operations, Engineering, Supply Chain, and Commercial teams to deliver compliant products and support growth.

The role requires strategic vision, strong quality governance, and proven leadership in a fast-paced manufacturing environment.

Qualifications

• FDA cGMP/GCP and 21 CFR Part 11 knowledge.
• Experience leading quality organizations and cross-functional change.
• Strong written and verbal communication skills.

Responsibilities

• Provide strategic leadership for site Quality and PQS governance.
• Oversee deviations, investigations, CAPAs, change controls, and training.
• Maintain inspection readiness and regulatory compliance.
• Lead customer audits and regulatory inspections, ensuring timely responses.
• Mentor quality staff and drive continuous improvement.

Skills

Regulatory compliance leadership

Quality governance

Cross-functional collaboration

Strategic thinking

Communication & documentation

Education

Bachelor's degree in science

5–7 years relevant experience

Job description

Sharp Clinical Services, located in Lehigh County, seeks an Associate Director of Quality to lead the Pharmaceutical Quality System and ensure global regulatory compliance. You will partner with Operations, Engineering, Supply Chain, and Commercial teams to deliver compliant products and support growth.

The role requires strategic vision, strong quality governance, and proven leadership in a fast-paced manufacturing environment.