Director of Quality Assurance, Medical Device jobs

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.

The Role:

• 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.

The Candidate:

• 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 limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

• Currently Catalent participates in the Ontario Immigrant Nominee Program (OINP) on a limited basis.

Pay:

The final salary offered to a successful candidate may vary within this range 140,000 – 190,000, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a global employer, and this salary range does not reflect positions that work in other countries.

Why you should join Catalent:

• Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)

• Group Retirement Savings –Registered Pension Plan (RPP) with employer contributions.

• Employee Reward & Recognition programs.

• Opportunities for professional and personal development & growth including tuition reimbursement.

Catalent offers rewarding opportunities to further your career! 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 new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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 DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.