Quality Compliance & Audit Readiness Lead

Kindeva; Maryland Heights (MO); On-site; USD 110,000 - 150,000; Full time

Job summary

Kindeva is seeking a Sr. Quality Compliance Specialist II to lead inspection readiness and ensure compliance with cGMPs across site operations. You will collaborate with business owners to review processes, procedures, and policies to maintain high quality and regulatory readiness.

The role emphasizes audit support, regulatory liaison, and continuous improvement to protect product safety and efficacy. Strong leadership and cross-functional communication are essential.

Qualifications

• Master's degree with 3-5 years of relevant work experience, or Bachelor's degree in a scientific field with 5-7 years of relevant work experience.
• Experience in pharmaceutical manufacturing is preferred.
• Excellent written and verbal communication, ability to share vision and data across all levels.

Responsibilities

• Ensure manufacturing operations and quality procedures comply with 21 CFR Part 210/211, 21 CFR 820, 21 CFR Part 4, Annex 1.
• Maintain and track internal and regulatory commitments for accuracy and timeliness.
• Assist staff in detecting and solving compliance issues in real time.
• Review, edit, and author SOPs, audit reports, and technical documents.
• Develop and deliver training on compliance policies and reporting systems.

Skills

Quality compliance

Audit readiness

GxP knowledge

Regulatory knowledge

Documentation & SOPs

Training & mentoring

Data analysis

Cross-functional collaboration

Problem solving

Education

Master's degree + 3-5 years

Bachelor's degree in Science/Engineering

Pharmaceutical manufacturing experience

Job description

Kindeva is seeking a Sr. Quality Compliance Specialist II to lead inspection readiness and ensure compliance with cGMPs across site operations. You will collaborate with business owners to review processes, procedures, and policies to maintain high quality and regulatory readiness.

The role emphasizes audit support, regulatory liaison, and continuous improvement to protect product safety and efficacy. Strong leadership and cross-functional communication are essential.