Senior Quality & Compliance Audit Lead

Sharp Clinical Services; Bethlehem (Northampton County); On-site; USD 95,000 - 130,000; Full time

Job summary

Sharp Clinical Services in the United States seeks a Senior Compliance Specialist to maintain and improve quality systems complying with FDA and global standards. You will independently lead customer, internal, and supplier audits as a SME within Quality, coordinating responses and CAPAs while driving operational quality.

The role requires 7+ years in cGMP, strong auditing and QA/QC knowledge, and ability to mentor teams and manage cross-functional projects, with a focus on regulatory

Qualifications

• Bachelor's degree in science or technical field preferred.
• Minimum 7 years in a cGMP environment.
• Advanced GMPs, GDPs, GLPs, auditing and QA/QC knowledge.
• Ability to communicate QA knowledge professionally and succinctly.
• Proven ability to lead audits and compliance initiatives independently.
• Experience with MS Office applications and quality management systems.
• Sound regulatory interpretation and decisive problem-solving.
• Strong teamwork, communication, and organizational skills.
• Demonstrated ability to guide others in quality processes.

Responsibilities

• Coordinate site audits and manage customer, internal, and supplier audits.
• Lead audit activities, responses, and CAPA plans.
• Monitor quality metrics, events, complaints, and change controls.
• Back-up Management Representative for inspections.
• Plan and execute internal and supplier audits per schedule.
• Develop and submit audit responses and corrective actions.
• Mentor staff and customers on QA processes and improvements.
• Support site process improvement initiatives.

Skills

GMP/GDP/GLP knowledge

Auditing

Quality Assurance/Quality Control

Regulatory interpretation

Audit leadership

Communication skills

Cross-functional collaboration

Microsoft Office / quality systems

Education

Bachelor's degree in science/technical field

Associates degree or equivalent

Tools

Quality Management Systems

Microsoft Office

Job description

Sharp Clinical Services in the United States seeks a Senior Compliance Specialist to maintain and improve quality systems complying with FDA and global standards. You will independently lead customer, internal, and supplier audits as a SME within Quality, coordinating responses and CAPAs while driving operational quality.

The role requires 7+ years in cGMP, strong auditing and QA/QC knowledge, and ability to mentor teams and manage cross-functional projects, with a focus on regulatory