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Job description
Description
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.
PRIMARY 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.
Requirements
QUALIFICATIONS:
Education and/or Experience:
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 and 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
TRAINING:
On the job training:
SDS/Hazardous Awareness
Good Manufacturing Practices (GMP)
Laboratory Procedures
Product knowledge
Reasoning Ability:
Teamwork/collaborative style of management
Good business acumen, judgment and maturity with the ability to differentiate strategic vs. non-strategic opportunities
Excellent organizational skills
WORK ENVIRONMENT:
Lab environment involving chemicals, solvents, gasses, and glassware
Laboratory bench work and documentation
Low to medium noise level
Temperature controlled environment
TOOLS AND EQUIPMENT:
Computer and printer
Phone
Copy machine
Appropriate personnel protective equipment (when necessary)
Lab equipment
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.
FLSA: Exempt
Benefits:
401(k)
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Tuition reimbursement
Vision insurance
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Worksite address
elgin, IL, 60122, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.