Associate Director, Device and Combination Product Compliance
Company: Disability Solutions
Location: Morrisville
Posted on: April 20, 2024
Job Description:
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 categoriesCatalent
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 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 . 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 .
Keywords: Disability Solutions, Cary , Associate Director, Device and Combination Product Compliance, Executive , Morrisville, North Carolina
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