Director of Quality Control

This is a well-established U.S. manufacturer of sterile injectables with more than 50 years in the market, operating as part of a global pharmaceutical group. The company has built its reputation on developing and delivering complex, hard-to-manufacture injectables and drug-shortage medicines that hospitals and clinics rely on every day. It continues to invest significantly in expanding and modernizing its U.S. manufacturing footprint — a rare combination of stability, scale, and forward momentum for quality professionals.

The Director, Quality Control is the laboratory leader standing between commercial sterile injectable production and the patients who receive it. The role directs analytical, microbiology, sterility, bioburden, and environmental monitoring programs across two central Ohio manufacturing facilities, in support of both operations and R&D. Recently elevated from a senior manager position to Director, it carries leadership of a QC laboratory of approximately 50 chemists and microbiologists and reports directly to the Vice President of Quality Assurance — a visible, high-impact seat in a quality organization that is actively building.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• Manage the day-to-day activities in the laboratories in support of both operations and R&D functions as well as Environmental Monitoring Technicians in manufacturing at the company’s two central Ohio manufacturing facilities.
• Manage testing programs including analytical, sterility, bioburden and microbiological tests as necessary.
• Manage, identify and introduce new testing methodologies for applicable testing procedures.
• Manage and perform trend analysis for all operations.
• Provide support in front of regulatory agencies eg: FDA/ CDER-CBER, customer audits, corporate auditors, Health Canada, EMA, internal audits and as required.
• Supervise the certification of laboratory technicians on various test procedures per USP, FDA, PDA and EU guidelines.
• Hire, train and manage performance of existing and future laboratory personnel and technicians.
• Write, review, and approve validation and qualification SOPs.
• Provide expertise in EMPQ qualifications, new sterile filler qualifications, new water systems qualifications, new laboratory space qualifications and disinfectant study qualifications.
• Ensure laboratories maintain compliance with cGMPs/GLPs, support validation, regulatory filing, R&D, Metrology, Engineering, QA, manufacturing and formulation operations.
• Identify, evaluate, purchase and qualify laboratory equipment.
• Direct, perform and resolve out-of-specification investigations, deviations and implement CAPAs.
• Have knowledge of and support the Sterility Assurance Utilities process, Cleaning & Disinfection process and Traffic & Gowning process of sterile manufacturing.
• Train, coach, mentor and supervise direct reports.
• Oversee, trouble shoot and investigate outsourced testing for products and components.
• Partner with Production, Regulatory Affairs, Engineering, and QA Compliance to strategize and organize implementation of new technology, processes, and products.
• Identify and facilitate process improvements to increase efficiencies in systems, operations, and personnel.
• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
• Position has responsibilities at multiple locations in central Ohio and provide input, as requested, with the company’s New York manufacturing site on microbiology issues.
• Perform any other tasks/duties as assigned by management.

The ideal candidate is an…