Quality Systems Specialist

Kindeva Drug Delivery • Lexington, KY

18h • Onsite

About The Position

At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. As a Quality Systems Specialist, you will play a critical role in ensuring quality oversight and compliance across pharmaceutical development, manufacturing, and testing. This position is responsible for supporting and maintaining quality systems, overseeing supplier quality programs, coordinating audits and compliance activities, and driving continuous improvement initiatives to ensure adherence to applicable regulatory requirements and company standards. You will collaborate closely with internal departments and external partners to strengthen quality processes, support inspections and audits, and contribute to the overall success of Kindeva's Quality organization.

Requirements

• Bachelor's degree or equivalent experience with a minimum of 3 years of pharmaceutical or medical device quality experience in a current Good Manufacturing Practice (cGMP) environment.
• Experience supporting quality systems, supplier quality programs, audits, compliance activities, investigations, and continuous improvement initiatives within regulated pharmaceutical, biotechnology, or medical device environments.
• Demonstrated ability to assess problems, identify solutions, implement corrective actions, manage multiple priorities, and meet established timelines in a fast-paced environment.
• Strong communication, collaboration, and technical writing skills with the ability to work effectively both independently and within cross-functional teams.
• Must be qualified to work with controlled substances.

Nice To Haves

• Experience with electronic Quality Management Systems (eQMS) such as MasterControl or Veeva preferred.
• Experience supporting internal and external quality systems activities is highly desirable.

Responsibilities

• Support the development, maintenance, and continuous improvement of quality systems to ensure compliance with current Good Manufacturing Practices (cGMPs), Good Practice (GxP) requirements, 21 CFR Part 11, and other applicable regulations.
• Review and approve quality documentation, including procedures, validation protocols, development reports, product complaint investigations, and other compliance-related records.
• Develop and maintain compliance metrics, trending reports, and quality system monitoring activities to support regulatory readiness and continuous improvement.
• Manage supplier quality activities, including supplier qualifications, Supplier Corrective Action Requests (SCARs), vendor change notifications, supplier quality agreements, and related quality assessments.
• Participate in and support internal audits, supplier audits, customer audits, regulatory inspections, and compliance assessments while providing recommendations and implementing improvements as appropriate.
• Collaborate with internal departments and external suppliers to address quality concerns and ensure ongoing compliance with company and regulatory expectations.
• Lead or support quality-related projects and continuous improvement initiatives designed to enhance the effectiveness and efficiency of quality systems and processes.
• Partner with Quality, Manufacturing, Technical Operations, and other functional teams to support business objectives, investigations, and compliance activities.
• Utilize electronic Quality Management Systems (eQMS) to support quality system processes and assist management with departmental priorities and special projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level