Director of Quality Position Summary: 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. 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. ~ Direct experience hosting and leading the preparation, management, and follow-up relating to FDA and HPFBI inspections. ~ Excellent computer skills including Microsoft Office Suite (Outlook, Excel, Access, Word). ~ Currently Catalent participates in the Ontario Immigrant Nominee Program (OINP) on a limited basis.

Comprehensive Benefit

Package (Health, Dental, Vision,



& Life Insurance) Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions. Opportunities for professional and personal development & growth including tuition reimbursement. Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.

Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance recent medicines from early development to clinical trials and to the market. personal initiative. Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] option is reserved for individuals who require accommodation due to a disability.

Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply.

Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. #

📌 Director Of Quality (Strathroy)
🏢 Catalent Pharma Solutions
📍 Strathroy