Director of Quality

Director of Quality - Sterile Manufacturing
Albany, OH | Full-Time | On-Site

We're working with a growing pharmaceutical manufacturer focused on sterile injectables to find an experienced Director of Quality to lead Quality Assurance and Quality Control operations at their 503B facility in Ohio. This is a key leadership role where you'll drive quality strategy, oversee compliance with regulatory standards, and lead a dedicated team through all aspects of product quality.

This is a great opportunity for someone who thrives in regulated environments and enjoys building strong, inspection-ready quality systems while mentoring a team.

What You'll Be Doing:

• Lead the site's QA and QC operations with full responsibility for compliance and product quality.
• Review and approve documentation, including SOPs, batch records, deviations, change controls, and investigations.
• Ensure successful execution and documentation of all validation activities.
• Host and lead site inspections by FDA, State Boards of Pharmacy, and other regulatory bodies.
• Manage vendor qualification and oversight programs.
• Oversee product labeling, incoming materials, and sample retention programs.
• Collaborate cross-functionally to support audits, quality agreements, and continuous improvement initiatives.
• Maintain and strengthen the site's Quality Management System (QMS), ensuring compliance with cGMP, USP 795/797, 503B regulations, and internal standards.
• Deliver regular quality metrics and insights to senior leadership.
• Mentor and develop a high-performing quality team, allocating resources to meet both business and compliance needs.

Who We're Looking For:

• Bachelor's degree in a scientific or technical discipline.
• 10+ years of experience in pharma, biotech, or medical device quality.
• At least 7 years in progressively senior quality roles, including 5+ years managing teams.
• Strong command of cGMPs, especially within sterile injectable manufacturing.
• Hands-on experience with 21 CFR Part 11-compliant systems and batch disposition processes.
• Experience interfacing directly with the FDA and other regulatory bodies.
• Skilled in managing third-party vendors, CMOs, and testing labs.
• Ability to travel up to 20%.

Please do not hesitate to apply for further information!