Job Information
Catalent Pharma Solutions Associate Director, Device and Combination Product Compliance in Morrisville, North Carolina
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:
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
152 hours of PTO + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
Competitive salary with bonus potential
Community engagement and green initiatives
Generous 401K match and Paid Time Off accrual
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement – Let us help you finish your degree or earn a new one!
GymPass program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .