Quality Manager Profile / Job Description

Job Overview 

The Quality Manager manages the department, provides quality oversight for all aspects of the manufacturing operations, and oversees the batch record review and disposition of in-process commodities and final products manufactured at the site. The Manager assures proper controls are instituted and maintained during the manufacturing, processing, packaging and warehousing of in-process and finished product. The Quality Manager is accountable for ensuring that manufacturing operations are in compliance with quality policies, procedures, standards, and specifications.

Responsibilities

• Responsible for ensuring appropriate sampling, inspection, and functional testing of final product samples.
• Lead problem identification and resolution efforts for quality related issues from the manufacturing operations. Investigate issues, define and direct implementation of solutions. Responsible for input to impact assessments and investigations for manufacturing related investigations.
• Ensure compliance to all requirements established for product manufactured and the systems supporting manufacturing to allow for timely release of in-process material and final product.
• Partner with manufacturing operations to identify and implement process improvements. Perform gap assessments of processes and implement corrective actions.
• Direct the operations of the quality function, including establishment of responsibilities and goals, supervision of staff, and achievement of objectives. Hire, train, develop and motivate department staff.
• Ensure the disposition of in-process commodities and final products meet all product release specifications and cGMP requirements. Leads problem identification and resolution efforts for quality related issues related to batch release. Advise and assist in the disposition of restricted material.
• Evaluate and approve plant documentation to ensure compliance to GMPs, specifications, and procedures.
• Assume delegate authority for Quality Assurance Director, when required.

Requirements

• College degree or equivalent operations experience in manufacturing environments
• Minimum of 3 years in related experience
• Experience working with quality systems, ISO and quality assurance.
• Strong organizational skills to manage, prioritize, schedule, and balance multiple projects simultaneously
• Ability to identify and resolve problems effectively, strong analysis and decision-making skills.
• Ability to initiate and effectively implement change
• Must have data analytical and problem-solving skills with the ability to manipulate large data sets.
• Strong communication skills, strong interpersonal skills to communicate effectively with all levels of personnel
• Experience developing and interpreting customer specifications
• Ability to work well without close supervision and the ability to make sound, high impact decisions.
• Must be a self-starter, and have ability to learn new information/processes