QA Lead, GMP Compliance & Process Excellence

Groupe Kardol; West Chester (Chester County); On-site; USD 70,000 - 115,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Healthcare coverage

Paid time off

Tuition reimbursement

Caregiving support

Job summary

Groupe Kardol in the United States is seeking a QA professional to oversee GMP documentation, batch release, and product disposition across operations. This role collaborates with QA and site teams to ensure compliant processes and strong quality controls.

Responsibilities include reviewing change controls, deviations, investigations, and ensuring adherence to quality systems while mentoring junior QA staff. The position is full-time and located on-site in West Chester, PA.

Qualifications

• Prior experience in pharmaceutical industry, operations, or Quality Assurance.
• Knowledge of cGMPs, Quality Systems, and pharmaceutical supply chain environment.
• Excellent verbal and written communication skills.
• Strong motivation to learn and improve.
• Strong problem-solving skills.
• Ability to coach and mentor peers.

Responsibilities

• Review and approve GMP documentation impacting operations and facilities.
• Disposition of incoming materials and finished product.
• Collaborate with QA professionals to ensure consistent application of quality systems.
• Execute QA processes: batch record review, product disposition, and issue resolution.
• Interface with site groups on projects to ensure GMP compliance.
• Lead process ownership and drive quality improvements across the site.
• Provide QA coaching to junior staff and other employees.

Skills

Quality systems

Communication

Problem solving

Mentoring

Education

Bachelor’s or Master’s in QA/regulatory affairs

Job description

Groupe Kardol in the United States is seeking a QA professional to oversee GMP documentation, batch release, and product disposition across operations. This role collaborates with QA and site teams to ensure compliant processes and strong quality controls.

Responsibilities include reviewing change controls, deviations, investigations, and ensuring adherence to quality systems while mentoring junior QA staff. The position is full-time and located on-site in West Chester, PA.