Director, Quality Assurance & Compliance – Pharma Manufacturing

Medline; Waukegan (IL); Presencial; USD 154 000 - 231 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Life and disability

401(k) contributions

Paid time off

Resumo da oferta

Medline Industries, LP seeks a Quality Director to lead the site Quality teams, shaping strategy and translating plans into actionable programs to ensure QSR, PQS, GMP, ISO, ICH compliance across products and processes.

You will collaborate with Plant Operations, prepare for internal and external audits, and align with senior leadership to ensure on-time delivery and customer satisfaction. Competitive rewards and bonus eligibility are offered.

Qualificações

• Typically requires a Bachelor's degree in Engineering, Science, or Technical Field.
• At least 7 years of experience in design/operation of medical device or drug product platforms or regulated industries.
• Proficiency in analyzing and reporting data to drive improvement and find solutions.
• Advanced Excel skills including pivot tables and data analysis.

Responsabilidades

• Provide leadership and direction to Quality teams to ensure quality and regulatory compliance.
• Partner with Plant Operations to drive continuous improvement and strong collaboration.
• Develop and implement a strategy for the Quality department based on quarterly reviews.
• Ensure site readiness for internal audits, external audits, and customer visits.
• Oversee QSR/QMS/PQS programs and compliance across departments.

Conhecimentos

Data analysis

Project coordination

Excel

Regulatory knowledge

Formação académica

Bachelor's degree in Engineering, Science, or Technical Field

Ferramentas

Excel

Descrição da oferta de emprego

Medline Industries, LP seeks a Quality Director to lead the site Quality teams, shaping strategy and translating plans into actionable programs to ensure QSR, PQS, GMP, ISO, ICH compliance across products and processes.

You will collaborate with Plant Operations, prepare for internal and external audits, and align with senior leadership to ensure on-time delivery and customer satisfaction. Competitive rewards and bonus eligibility are offered.