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Associate Director, Device and Combination Product Compliance - Morrisville North Carolina
Company: Disability Solutions Location: Morrisville, North Carolina
Posted On: 05/09/2024
Position Summary:Catalent Pharma Solutions in Morrisville, NC is hiring an Associate Director for the Quality group. This person is responsible for implementing and sustaining a Quality Management System that meets all customer and regulatory agency requirements and expectations. The Associate Director will also ensure all aspects of Design Controls for medical device/combination products are implemented and sustained. This position will support onboarding of new medical devices/combination products, including design and process of Failure Mode, Effect Analysis, and Device Master Record.This is a full-time position: Monday - Friday, 8:00AM - 5:00PM.Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.--The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.----Catalent is committed to a Patient First culture through excellence in quality and--compliance, and to the safety of every patient, consumer, and Catalent employee.--The Role - Responsible for administrating Quality Systems including document control, change control, and internal/external audits.
- Ensure compliance to regulations for medical device and combination products
- Write, revise, and review SOPs for approval associated with design control
- Support new combination product introduction and maintenance of Device Master Record for commercial and clinical programs
- Support change controls associated with design controls
- Support FMEA associated with the design and production of medical device and combination products
- Support product complaint investigation for combination products
- Recommend modification to operating policies
- Serve as a QA resource for design control activities
- Staffing responsibilities for a single functional area or department of Catalent with moderate financial responsibilities
- All other duties as assigned;The Candidate
- Bachelor's degree in Science, Engineering, or similar is required
- 7 or more years of Quality Management experience in medical device and/or combination product development is strongly preferred
- 3 or more years of supervisory experience is strongly preferred
- Expertise in FDA 21 CFR Parts 820, 210, and 211 quality system requirements is required
- Expertise in medical device and combination product requirements is required
- Experience working in or interacting with an analytical laboratory is preferred
- Exposure to a pharmaceutical manufacturing environment is strongly preferred
- Experience working or interacting with FDA inspectors is strongly preferred
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;Why you should join Catalent:
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