Global Quality Systems & Compliance Lead

Global Quality Systems & Compliance Lead Kindeva Drug Delivery Careers - 2.1 Woodbury, MN Job Details Full-time $129,500 - $171,750 a year 1 hour ago Qualifications Regulatory inspections Pharmaceutical regulatory compliance Data quality management Project management Quality systems Stakeholder management Full Job 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 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

System Innovation Drive adoption of innovative technologies and digital solutions to improve quality processes. Data Integrity 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. Continuous Improvement & Best Practices 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 Regulatory Compliance/Inspection Management 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 Knowledge Sharing & Training 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. 12+ 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. Strong understanding of CDMO experience preferred 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.

PHYSICAL QUALIFICATIONS

Position requires vision acuity testing and onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short- or long-term basis. The candidate must be able to complete aseptic gowning qualification and work in a Grade A/B classified area. It is required to sit, stand and occasionally lift items (up to ~25 pounds), performing the duties of this position. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications, and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site. 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 Today!