Global Quality Systems & Compliance Lead
Kindeva•Woodbury, MN
•Onsite
About The Position
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.
Requirements
- 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
