Director of Quality (Pharmaceutical Manufacturing)

FIRST PRIORITY, INC•Elgin, IL

1d•Onsite

About The Position

First Priority, Inc. is the animal health industry's premier manufacturer and supplier of generic pharmaceutical products located in Elgin, IL. We are seeking a dynamic and experienced Director of Quality to lead our animal pharmaceutical manufacturing quality assurance and control operations. In this pivotal role, you will drive the development, implementation, and continuous improvement of robust quality systems that ensure our products meet the highest standards of safety, efficacy, and compliance. Your leadership will foster a culture of quality excellence across manufacturing processes, regulatory adherence, and inspection protocols, empowering the organization to deliver life-changing animal medicines with confidence. This is an exciting opportunity for a proactive leader passionate about advancing pharmaceutical quality standards on a large scale. GENERAL SUMMARY: Responsible for the organizational elements of First Priority’s Quality Control, Quality Assurance and R&D. This responsibility includes, but is not limited to, the effective planning and organization of personnel and workflow utilization in order to implement the timely submission, approval, validation, testing and release of products and processes in accordance with applicable internal quality system policies, procedures, and external regulations and standards that govern the products manufactured, labeled, tested, stored, promoted and/or distributed by or for First Priority Inc.

Requirements

B.S. degree in Biology or Chemistry or related sciences
Minimum of 10 years of pharmaceutical experience
Must have FDA regulatory knowledge and experience.
Minimum of 5 years’ experience leading a Quality function.
Knowledge and/or experience in product formulation of liquids, ointments, powders, tablets and injectables.
Knowledge of cGMP
Knowledge of Regulatory Affairs required
Compliance and Validation experience preferred
Strong communications skills, ability to problem solve and use of critical thinking.
Good level of computer literacy
Change agent with the ability to influence all levels in the organization

Nice To Haves

Compliance and Validation experience preferred

Responsibilities

Promoting quality achievement and performance improvement throughout the organization.
Leads all regulatory inspections and responsible for all regulatory responses review and final review of all regulatory filings prior to submission.
Setting QA compliance objectives and ensuring that targets are achieved.
Assessing the product specifications of the company and its suppliers, and comparing with customer requirements.
Working with purchasing staff to establish quality requirements from external suppliers.
Ensuring compliance with national and international standards and legislation.
Establishing standards and clearly defined quality methods for staff and all employees to apply.
Defining quality procedures in conjunction with operating staff.
Setting up and maintaining controls and documentation procedures.
Identifying relevant quality-related training needs and delivering training.
Ensuring tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary.
Supervising managerial staff ensuring that objectives are established and accomplished.
Writing technical and management systems reports.
Ability to use change intervention tools and techniques to gain acceptance of a quality culture.
Liaising with customers' auditors and ensuring the execution of corrective action and compliance with customers' specifications.
Participate in special projects when the business need arises.