GLP Quality Assurance Lead — Audits & Compliance

Kelly Services; Montclair (NJ); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Transit spending account

Paid holidays

Paid sick leave

Retirement savings plan

Job summary

Kelly Services is seeking a GLP QA Expert to lead complex audits and oversee quality systems in Somerset, NJ. You will mentor junior QA staff, drive continuous improvement, and own QA focus areas such as vendor qualifications or process audits.

You will ensure GLP compliance, support regulatory inspections, and contribute to QMS development while maintaining high inspection readiness across departments.

Qualifications

• Strong knowledge of GLP and regulatory expectations to ensure compliance.
• Ability to lead audits, assess quality risks, and drive CAPAs.
• Experience mentoring junior QA staff and contributing to QMS.
• Ability to participate in inspections and sponsor audits.

Responsibilities

• Plan, execute, document, and follow up on complex audits (study, facility, process, system) and vendor qualifications.
• Prepare and finalize Quality Assurance Statements and related quality docs.
• Support regulatory inspections and sponsor audits, coordinating activities.
• Own QA focus areas such as Vendor Qualifications or Process Audits.
• Conduct risk assessments and advise on critical business decisions.
• Lead or support investigations into deviations with root-cause analysis and corrective actions.
• Ensure GLP compliance and identify improvement opportunities.
• Mentor QA staff and support onboarding and training.
• Represent QA in cross-functional quality initiatives.
• Participate in audit planning, scheduling, and risk-based prioritization.
• Support QMS development and maintenance and maintain inspection readiness.
• Improve audit methodologies, tools, templates, and processes.

Skills

Quality & Regulatory Expertise

Analytical Thinking

Communication

Leadership & Mentoring

Assertiveness & Collaboration

Continuous Improvement

Ownership & Accountability

Job description

Kelly Services is seeking a GLP QA Expert to lead complex audits and oversee quality systems in Somerset, NJ. You will mentor junior QA staff, drive continuous improvement, and own QA focus areas such as vendor qualifications or process audits.

You will ensure GLP compliance, support regulatory inspections, and contribute to QMS development while maintaining high inspection readiness across departments.