Compliance Director (Banking) jobs in Raleigh, NC

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

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Experience level:

• 6 years
• 7 years

Schedule:

• Monday to Friday

Application Question(s):

• Do you have experience in Quality Management??

Ability to Relocate:

• Morrisville, NC 27560: Relocate before starting work (Required)

Work Location: In person