Job Description

JOB SUMMARY:

We are seeking a highly motivated and experienced Quality Systems Manager to lead and support

corporate quality initiatives across multiple sites. This individual will oversee the Quality Systems

Team, ensuring compliance with cGMP guidelines, regulatory requirements (21 CFR Parts 11, 210,

211), and internal quality standards. The role involves managing document control, training,

change control, and quality events, while also serving as a key resource for audits, validations,

and continuous improvement projects.

JOB QUALIFICATIONS:

· Bachelor's degree in Scientific or Technical Field

· Proficient in Microsoft Office applications, including Word, Excel, and PowerPoint

· Strong understanding of the principles and application of cGMP guidelines and regulations in 21 CFR Parts 11, 210, 211

· Minimum of 4 years of experience in a leadership role

· Exceptional verbal and written communication skills including technical writing is required

· Excellent planning, time-management, problem-solving, and organizational skills required

· Experience in Enterprise Resource Planning (ERP) software, Oracle system preferred

· Experience in Quality Management System software, such as Agile or TrackWise

· Strategic thinker with the ability to manage multiple projects and tasks simultaneously

· Ability to train people (public speaking)

· Spanish language proficiency is a plus

POSITION RESPONSIBILITIES:

· Responsible for creating and revising Standard Operating Procedures, Work Instructions and other controlled documents as needed

· Create and present corporate GMP training for all manufacturing sites (5 in USA)

· Oversee quality systems team, including corporate training, document control and change control functions

· Support regulatory, third party and customer audits for all sites

· Collaborate with the Systems Validation team to support project requirements

· Lead Internal Quality projects for compliance and continuous improvement

· Interface with all departments on changes, projects, and training

· Support Corporate quality training for all sites as needed, including creating training content

· Support New Hire cGMP training as needed

· Work with Document Control personnel to proofread new and revised documents in Agile

· Enter and maintain data in the validated training system

· Serve as a backup for Change Analyst responsibilities, including document, protocol, and general CRN workflows

· Review and approve change controls for Quality related to job functions

· Monitor and route corporate quality events including but not limited to deviations, investigations, and CAPAs.

· Compile and report on corporate quality metrics

· Provide support to the Director of Quality with various departmental needs

PHYSICAL REQUIREMENTS:

· Work safely and adhere to all OSHA regulations as well as company safety policies and procedures

· Work in a manufacturing environment, when necessary

· Exposure to vitamins, mineral, herbal, and OTC products; No allergies

· Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements

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