Director of Quality

Director of Quality

Position Summary:

Work Schedule:

8:00 AM - 4:30 PM or 8:30 AM - 5:00 PM with a 30-minute lunch. 100% on-site The newly launched manufacturing facility on Adair Blvd marks a pivotal expansion of Catalent’s Zydis® technology, a globally renowned, fast-dissolve oral dosage form that has transformed the lives of millions of patients worldwide. This is your opportunity to join a dedicated team at the forefront of pharmaceutical manufacturing.

At Adair, you’ll play a vital role in the startup of a site built for innovation and excellence, from installation and qualification to regulatory approval and commercial manufacturing. Reporting to the VP, Quality for Pharma Consumer Health, the Zydis Strathroy Director of Quality is accountable for both Commercial Quality Assurance and Quality Control activities within Zydis Strathroy manufacturing site and for other quality programs as assigned across Catalent.

The Director of Quality is responsible for overseeing, coordinating, and managing the activities involved in planning, implementing, and maintaining the Catalent Quality Management Systems (QMS) at the Zydis Strathroy facility. This role leads the quality function, ensuring the site meets regulatory, compliance, Catalent and customer expectations.

Identify and achieve key company and departmental strategies, tactics and objectives relating to product quality and cGMP compliance. This includes projects to achieve regulatory approval for manufacturing and packaging of drug products. Lead and facilitate the implementation and ongoing management and improvement of the Quality Management System. Reviews and approves appropriate documentation for regulatory submissions where required. Assist in establishing current and long-term strategies and set appropriate operating plans for future development of Zydis Strathroy business.

Instill 'The Catalent Way' discipline and reliability into the Quality Management System in pursuit of best practice operations from the outset. Ensure effective completion and follow up of deviations and CAPA's to drive deviation reductions and associated key performance indicators. Works closely with the operations team to ensure that the Quality Management System and Quality Plan support current quality management strategy themes, corporate objectives, and industry requirements.

Collaborate with the operations team to drive systematic process improvements across the organization. Monitor and participate in Quality Trend programs and analysis for quality metrics including but not limited to Deviations, CAPA/Corrections, BRRFT, Customer Complaints, Reprocessing, etc. Strategic Safety Leadership:
Champion a safety-first culture by ensuring all operations under your oversight adhere to corporate safety policies and procedures. Promote consistent use of the STAR (Stop, Think, Assess, Respond) method across teams to drive proactive risk management and continuous safety improvement. Other duties as assigned.

• Bachelor's Degree in Science or related technical field required.
• 7+ years of experience working in a manufacturing, pharmaceutical and/or GMP facility in a leadership role.
• Understanding of the overall business needs/objectives and ability to respond quickly to a changing regulatory environment.
• Expertise in contemporary tools to meet current and advancing cGMP requirements.
• Direct experience hosting and leading the preparation, management, and follow-up relating to FDA and HPFBI inspections.
• Excellent verbal and written communication skills and Ability to multi-task and prioritize.
• Excellent computer skills including Microsoft Office Suite (Outlook, Excel, Access, Word).
• Demonstrable leadership experience at Catalent (including but not…