Global Quality Systems & Compliance Lead
WFA Digital Insight
The remote job market has seen a significant increase in demand for quality and compliance specialists, with a 25% growth in job postings in the last year. This is largely driven by the need for companies to navigate complex regulatory landscapes. As a Global Quality Systems & Compliance Lead, you will be at the forefront of this effort, utilizing your digital skills to drive innovation and ensure compliance. With the right skills and experience, you can thrive in this role. Before applying, make sure you have a solid understanding of international regulatory requirements and experience with quality management systems.
Job Description
About the Role
The Global Quality Systems & Compliance Lead role is a critical position that requires a deep understanding of quality management systems and regulatory compliance. As a key member of the team, you will be responsible for driving strategic initiatives that enhance global quality through innovation, compliance, and harmonization. Your day-to-day tasks will involve developing and maintaining global standard operating procedures (SOPs) and policies for quality, as well as ensuring compliance with international regulatory requirements.The success of this role is crucial to the company's mission of saving lives and ensuring better health and well-being for patients around the world. You will be working closely with cross-functional teams to identify and implement process optimization opportunities, collect and disseminate best practices, and develop quality management maturity models.
The company is committed to creating a culture of compliance and ethical business practices, and as the Global Quality Systems & Compliance Lead, you will play a key role in fostering this culture. You will be responsible for creating and managing inspection management tools, developing and delivering training content, and facilitating knowledge-sharing forums and communities of practice.
What You Will Do
- 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
- 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 their impact on each location
- Create a culture and have discussions related to near misses during inspections/audits
What We Are Looking For
- 5+ years of experience in quality management and compliance
- Strong understanding of international regulatory requirements (FDA, EMA, ISO, etc.)
- Experience with quality management systems (QMS) and auditing
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced, dynamic environment
- Strong analytical and problem-solving skills
- Experience with digital solutions and innovative technologies
- Certification in quality management (CQM, CQA, etc.)
Nice to Have
- Experience with data analytics and visualization tools
- Knowledge of lean principles and process improvement methodologies
- Certification in regulatory affairs (RAC, etc.)
- Experience with inspection management tools and systems
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a global team and make a meaningful impact
- Flexible working hours and remote work options
- Professional development and training opportunities
- Access to the latest digital tools and technologies
- Recognition and reward programs for outstanding performance
- Comprehensive health and wellness programs
- Generous paid time off and vacation policy
How to Stand Out
- Make sure to highlight your experience with quality management systems and regulatory compliance in your application.
- Familiarize yourself with the company's products and mission to demonstrate your passion and understanding of the industry.
- Showcase your ability to work in a fast-paced, dynamic environment and your experience with digital solutions and innovative technologies.
- Prepare examples of your experience with process optimization, data analysis, and quality management maturity models.
- Be ready to discuss your approach to creating a culture of compliance and ethical business practices.
- Review the company's values and mission to ensure you are a good fit for the company culture.
- Don't be afraid to ask questions during the interview process to demonstrate your interest and engagement with the role.
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