Quality Manager

The ARM Group is actively hiring for a Full Time - Quality Manager for one of our leading clients in Aurora, IL

General Overview

The Quality Manager is responsible for the overall quality operations of the plant, that involves planning and execution of robust quality systems and processes, meeting our customers’ expectations as well as the applicable regulatory/health authority requirements.

Key Responsibilities

• Develops, deploys, and sustains a comprehensive quality assurance program, by establishing the appropriate policies, procedures, and controls, that ensures reliable supply of consistent quality products conforming to established standards, regulatory requirements, and customers’ expectations.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure the state of compliance for the plant at all times.
• Serves as the liaison between the company and the various governmental agencies, including FDA.
• Be the Quality point person for all our customers, suppliers, and regulators.
• Establishes, deploys, and operationalizes effective Quality Management System (QMS) in line with the international guidelines (viz., ISO 22716, USFDA Part 210, 211 etc.) to demonstrate compliance to cGMP requirements for all categories of products that we produce/supply.
• Hosts quality inspections by the regulatory agencies/health authorities (FDA), quality audits by the third-party accreditation bodies (ISO) and by our customers. Prepares audit responses and drives actions to close the audit/inspection observations with evidence of it being effective and sustainable.
• Be the advocate of cGMP and quality in all operations. Conducts periodic training for all involved in the cGMP activities, across functions and levels at the plant.
• Establishes suitable processes and controls for new products and/or processes introduction into plant.
• Creates and drives execution of Validation Master Plan (covering manufacturing/packing/cleaning processes, equipment/utilities qualifications, testing methods, computer systems etc.) for the plant, defining clear strategy/approach and frequency that ensures plant operates in validated state to meet the applicable regulatory compliance and achieve customer satisfaction.
• Be the custodian of all GXP documents, including Product Formulations, Products/Materials Specifications, Test Methods, Manufacturing Work Instructions, Batch Manufacturing/Packing Records, and any other documents received from our customers.
• Works directly with Operations to ensure that quality inspections, statistical process control analyses and internal audits are conducted as specified to enforce requirements and meet specifications. Responsible for administrating inspection procedures and standards.
• Establishes and ensures that quality control testing and/or inspections are conducted for the incoming raw/packaging materials, in-process/bulk product and finished products, in accordance to the relevant specifications. Owns the disposition decision based on conformance to agreed specifications.
• Investigates customer complaints promptly, leads quality investigations to identify the root-cause/s and drives systemic resolution of all quality related issues, if required through robust CAPA.
• Meets department financial objectives through the development and management of annual budget.
• Identifies department goals and delivers results tied to departmental and plant goals.
• Manages and develops direct reports through goal development, addressing performance and identifying training.
• Ensures timely completion of all required departmental and plant safety training. Ensures a safe working environment.

Qualifications

Basic Minimum Requirements

• Meet the legal minimum age requirement.
• Authorized to work in the United States.
• BS Degree in Chemistry, or Pharmacy, or Technology or related field.
• 5 years of experience in an FDA regulated manufacturing environment.
• 5 years of experience working in a Quality environment with comprehensive knowledge of cGMP and FDA regulations.
• Experience managing direct reports.
• Experience conducting/managing internal and external quality audits, FDA audits, customer audits.
• Advanced skills in Microsoft Office (Outlook, Word, Excel, and Power Point).

Other Required Skills

• Ability to work independently and as part of a team.
• Strong attention to detail, planning and organizational skills.
• Strong written, verbal, and interpersonal skills.

Preferred Qualifications:

• Six sigma certification.
• Professional course in Regulatory Affairs.
• Experience in an environment of high-speed assembly lines.

Physical Demands:

• Able to sit for long periods of time utilizing a computer.
• Able to stand for long periods of time on the manufacturing shop floor.
• Exposure to dust, noise and odors.
• Work may be performed in a manufacturing environment.
• Lifting up to 20 lbs.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Disclaimer:

ARM GROUP is committed to fostering a diverse and inclusive workplace. We are an Equal Employment Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis.

We actively encourage applications from individuals with diverse backgrounds, including people with disabilities. Accommodations are available upon request for applicants participating in all aspects of the selection process.

By applying for this job, you consent to allow representatives of ARM GROUP LLC to contact you regarding your candidacy. This may include communication via email, phone, text, or other means deemed appropriate by ARM GROUP LLC. Rest assured, your information will be handled confidentially and used solely for recruitment purposes.

It’s important to note that ARM Group LLC does not interfere in the decision-making process regarding your selection or rejection. The ultimate decision to hire or reject your candidacy lies solely with the client organization, with whom we have an agreement to source candidates for their consideration

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. All applicants must submit to background check and drug screening. Applicants for this position must be legally authorized to work in the United States. Please be aware that this position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.