Director of Quality (Pharmaceutical Manufacturing)

About the Role

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.

Responsibilities

• Promote quality achievement and performance improvement throughout the organization.
• Lead all regulatory inspections and be responsible for all regulatory responses, review, and final approval of all regulatory filings prior to submission.
• Set QA compliance objectives and ensure targets are achieved.
• Assess product specifications of the company and its suppliers, comparing with customer requirements.
• Work with purchasing staff to establish quality requirements from external suppliers.
• Ensure compliance with national and international standards and legislation.
• Establish standards and clearly define quality methods for staff and all employees to apply.
• Define quality procedures in conjunction with operating staff.
• Set up and maintain controls and documentation procedures.
• Identify relevant quality-related training needs and deliver training.
• Ensure tests and procedures are properly understood, carried out, and evaluated, and that product modifications are investigated if necessary.
• Supervise managerial staff to ensure objectives are established and accomplished.
• Write technical and management systems reports.
• Use change intervention tools and techniques to gain acceptance of a quality culture.
• Liaise with customers' auditors and ensure execution of corrective action and compliance with customers' specifications.
• Participate in special projects when the business need arises.

Requirements

• B.S. degree in Biology, 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.

Skills

• Teamwork/collaborative style of management.
• Good business acumen, judgment, and maturity with the ability to differentiate strategic vs. non-strategic opportunities.
• Excellent organizational skills.

Training

• On the job training: SDS/Hazardous Awareness.
• Good Manufacturing Practices (GMP).
• Laboratory Procedures.
• Product knowledge.

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.

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.

FLSA: Exempt