Senior Quality Assurance Manager

Job title: Senior Quality Manager

Location: Illinois.

I am currently partnered exclusively with a Personal Care Contract Manufacturer, in search for a Senior Quality Manager based in Illinois. This individual must be well versed with Quality Assurance and Quality Control, having experience in a fast paced manufacturing environment.

This company are offering a relocation package for candidates based in the USA.

*No remote option, on site in Illinois.

Essential requirements

• Personal Care Skincare/OTC/Bodycare experience - dietary supplements/nutraceutical/ pharmaceutical Quality experience admirable.
• 8-10 years of Personal Care experience, Contract Manufacturing experience admirable.
• Must have a strong understanding of MoCRA.
• Must be well versed with FDA regulated environments, having a strong understanding of 21 CFR 210/211/820, ISO22617, MoCRA.
• Multi site experience admirable.

Responsibilities

• Comply with Good Manufacturing Practices (GMPs) and relevant laws and regulations for cosmetics and OTC products.
• Develop and enforce global quality policies and procedures aligned with FDA regulations and international standards (e.g., MoCRA, ISO 22716, ISO 13485, 21 CFR Part 11, 21 CFR Part(s) 210 & 211).
• Understand and confirm the feasibility of our customers quality requirements to ensure can meet expectations.
• Oversee or support regulatory inspections and coordinate consistent site readiness efforts
• Facilitate prompt and sustainable resolution of quality complaints.
• Implement a comprehensive audit process to ensure that our systems and procedures meet requirements of cGMP.
• Complete customer complaints and non-conformance investigations related to Production and the Quality Control departments and implement CAPAs.
• Conduct internal audits and attend all external audits.
• Lead all internal and external cGMP audits, managing Quality Staff in the defined area of Compliance and Assurance.
• Work with top management personnel regarding financial decisions and fiscal budgets for Quality Assurance Department and Company.
• Complete risk based internal audits for departments, develop and implement CAPAs based on audit observations.
• Lead and participate in facility Lean Manufacturing operations through Kaizens, RCAs, Gemba, continuous improvement tools etc.
• Effective training to personnel of GMPs during daily operations, new employee orientation and periodic refresher training.

Education

• Bachelor’s Degree in Business, Science, Engineering, or related field with 8 years of relevant work experience.
• Master’s degree in business, Science, Engineering, or related field with 5 years relevant work experience.

Skills

• Knowledge of Good Manufacturing Practices (cGMPs) is required.
• Experience and knowledge in Cosmetic, Personal Care, OTC drug, and Medical Device regulations with FDA, Health Canada, and other Foreign Markets.
• Ability to perform basic mathematical calculations.
• Performs work using good organizational and time management skills.
• Performs work with a high degree of accuracy and attention to detail.
• Works with minimum supervision.

This is an exciting opportunity to join a fast-growing company and contribute to success in the Personal Care industry. This company has excellent progression opportunities.