Quality Systems Specialist at Kindeva Drug Delivery

Lexington, Kentucky, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Aug, 26

Salary

0.0

Posted On

30 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems Management, cGMP Compliance, Supplier Quality, Internal Auditing, Technical Writing, eQMS, Corrective and Preventive Actions, Regulatory Compliance, Validation Protocols, Risk Assessment, Cross-functional Collaboration, Compliance Metrics

Industry

Pharmaceutical Manufacturing

Description

Our Work Matters At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make 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. Responsibilities Quality Systems & Compliance 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. Supplier Quality & Audit Support 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. Project Leadership & Cross-Functional Support 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. Qualifications 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. Experience with electronic Quality Management Systems (eQMS) such as MasterControl or Veeva preferred. Experience supporting internal and external quality systems activities is highly desirable. Must be qualified to work with controlled substances. Physical Requirements Ability to regularly use computers, electronic systems, and training materials for extended periods of time. Ability to effectively communicate through both telephone and electronic means. Ability to regularly stand and walk for extended periods throughout the workday. Must occasionally lift and/or move up to 25 pounds. Ability to use proper lifting techniques, remain aware of workplace hazards, and follow all site safety procedures. #LI-Onsite California residents should review our Notice for California Employees and Applicants before applying. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral. Equal Opportunity Employer: Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

Responsibilities

The role focuses on maintaining quality systems and ensuring compliance with cGMP and GxP regulations across pharmaceutical development and manufacturing. Key duties include managing supplier quality programs, coordinating audits, and driving continuous improvement initiatives.