Quality Manager – Permanent – Illinois

Proclinical is seeking a Quality Manager for a growing global specialty chemicals company based in Illinois.

Primary Responsibilities:

In this role, you will lead and maintain the site Quality Management System, lead the QA/QC team to ensure the site maintains its quality registrations, e.g. ISO 9000, and passes all regulatory and customer audits. You will ensure the site meets cGMP and IPEC requirements.

The position is based at their site in Illinois (4 days per week onsite, 1 day per week remote).

Skills & Requirements:

• Bachelor’s degree in chemistry, or related science subjects. Advanced degree preferred.
• Five or more years working in a quality environment involving quality systems and a knowledge of quality control.
• In-depth knowledge of ISO 9000, cGMP, IPEC, COSMOS, RSPO and relevant certification standards.
• Proven success in regulatory compliance, quality audits, and managing customer/regulatory inquiries.
• Ability to drive quality and compliance with a sense of urgency and attention to detail.
• Ability to lead teams and collaborate cross-functionally.

The Quality Manager will:

• Develop, update and lead the site Quality Management System to ensure the site maintains its quality registrations e.g. ISO 9000 and FSSC 22000/22002 with GFSI status.
• Lead and actively participate in the site’s internal auditor program for ISO 9000 Quality so it meets all quality and customer standards. Provide coaching as needed for auditors and new auditors.
• Assist all departments to ensure quality procedures, documents and actions are renewed/completed or updated in a timely fashion consistent with the QMS.
• Assist Sales/Marketing/Technical Service to retain existing business or obtain new business by providing the necessary quality, and technical knowledge and assistance both for the products and their applications in the market. This can cover quality questionnaires, specifications, and other documentations/certifications.
• Actively lead/participate in various quality assurance and quality control activities on the site e.g. in terms of documentation, product monitoring and quarterly quality monitoring of products so that quality and regulatory standards are maintained.

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or [email protected].

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.