Global Quality Systems & Compliance Lead
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 The Global Quality System & Compliance Lead is responsible for driving strategic initiatives that enhance global quality through innovation, compliance, and harmonization. This role ensures robust governance of emerging technologies, maintains data integrity standards, and fosters continuous improvement across all sites. The position serves as a global subject matter expert, enabling best practice sharing, training development, and alignment with regulatory requirements. Role Responsibilities Drive adoption of innovative technologies and digital solutions to improve quality processes. Develop and maintain global SOPs and policies for quality. Ensure compliance with international regulatory requirements (FDA, EMA, ISO, etc.). Establish governance frameworks for data integrity across global operations. Identify and implement process optimization opportunities. Collect, standardize, and disseminate best practices across global sites. Creation of white papers for key topics Manage the Quarterly Management Review process across the organization Develop Quality Management Maturity Models (QMM) for each quality system and track measurements, work with Systems to implement improvements Develop and execute a comprehensive regulatory compliance strategy aligned with business objectives. Issue and track regulation changes and how they impact each of the locations. Identify gaps and mitigate tasks. Create a culture and have discussions related to near misses during inspections/audits Foster a culture of compliance and ethical business practices Creation and management of inspection management tools Create and manage Inspection Readiness program including scoring metrics Develop and deliver training content for global quality and inspection management/compliance topics. Facilitate knowledge-sharing forums and communities of practice. Lead compliance training, programs for employees and management Basic Qualifications Bachelor’s degree in Life Sciences, Engineering, Quality Management, or related field degree preferred. CDMO experience, preferred 8+ years of experience in Quality Systems within a regulated industry (medical devices, pharmaceuticals, or similar). Strong understanding of global regulatory requirements and data integrity principles. Familiarity with AI governance and emerging digital technologies. Excellent communication, leadership, and stakeholder management skills. Strong project management skills and ability to manage multiple priorities. Experienced in regulatory inspections and interactions with agencies such as FDA, EMA, MHRA, etc. #LI-remote #LI-BM1 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!