Senior Quality Compliance Lead — Audit Readiness

Kindeva Drug Delivery; Missouri; On-site; USD 110,000 - 140,000; Full time

Job summary

Kindeva Drug Delivery seeks a Sr. Quality Compliance Specialist II to lead inspection readiness and ensure adherence to cGMPs, regulations, and internal procedures across the site.

You will collaborate with business owners to close gaps and prepare for regulatory and customer audits. The role requires advanced education with years of pharma quality experience, strong communication, and the ability to train staff on compliance policies and SOPs.

Qualifications

• Master’s degree with 3-5 years of relevant work experience or a scientific Bachelor’s degree with 5-7 years of relevant work experience or comparable background.
• Experience in pharmaceutical manufacturing preferred.
• Excellent written and verbal communication across levels and regulatory agencies.

Responsibilities

• Ensuring manufacturing operations and quality procedures comply with 21 CFR Part 210/211, 21 CFR 820, 21 CFR Part 4, Annex 1.
• Maintaining and tracking internal and regulatory commitments for accuracy and timeliness.
• Assist and support manufacturing staff in detecting and solving compliance issues in real time.
• Review, edit, and author SOPs, audit reports, and other technical documents.
• Develop and provide training on compliance policies, practices, and reporting systems.
• Lead site inspection readiness and support audit activities with customers and regulators.
• Participate in internal audits and drive closure of observations.
• Assist in process improvement and KPIs reporting to Management.

Skills

Quality compliance

Inspection readiness

Audit support

Regulatory knowledge

Analytical thinking

Education

Master's degree in science

Bachelor's degree in Science

Tools

Microsoft Office Suite

Job description

Kindeva Drug Delivery seeks a Sr. Quality Compliance Specialist II to lead inspection readiness and ensure adherence to cGMPs, regulations, and internal procedures across the site.

You will collaborate with business owners to close gaps and prepare for regulatory and customer audits. The role requires advanced education with years of pharma quality experience, strong communication, and the ability to train staff on compliance policies and SOPs.